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Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users

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1. Background and Introduction

A pacifier is an article with a nipple intended for a young child to suck on, but that is not

designed to help a baby obtain fluid. A pacifier usually has a guard or shield at the base of

the nipple that keeps the pacifier from being sucked completely into a child’s mouth. It also

has a handle or ring, usually on the other side of the guard or shield from the nipple that is

used to hold or grasp the pacifier. (Source: US CPSC, Requirements for Pacifiers, 16 C.F.R ,

Part 1511)

A pacifier is an article consisting of a teat that is intended for a baby to suck or bite upon,

but it is not designed to facilitate a baby obtaining fluid and usually includes a shield, a ring

and a plug. The pacifier may be made as a one-piece construction or as an assembly of

separate component parts. (Source: MS1156:1989)

Shield is a structure located at the base of the teat to prevent the pacifier from being

completely drawn into the baby’s mouth. (Source: MS1156:1989)

On July 20th

2010, US CPSC1 has issued a recall of 45000 baby pacifiers for choking and

aspiration. The nipple can separate from the base easily, the pacifier handle is too long, the

mouth guard is too small and there are no ventilation holes on the mouth guard. The

pacifier could pose a choking and aspiration hazard to young children. Earlier on in

November 2009, another brand of infant pacifier was recalled by CPSC due to similar design

flaw that could pose choking risk to babies.

2. Potential hazards Related to Baby Pacifiers

Hazards posed by pacifiers and sippy cups can be categorized as chemical or physical

hazards. Physical hazards are result of design issues caused by protruding parts and strings

attached which can inflict injury and strangulation risks respectively to the child. Chemical

hazards usually results from use of banned or excessive substance in the dye or material of

the products. For example BPA is a building block for polycarbonate plastic material used to

make plastic feeding bottles. Phthalates are additives which gives plastic effect to plastic so

that it can be easily formed. Dyes use to decorate or give color to the plastic receptacles

may contain excessive lead or Plumbum (Pb).

2.1. Migration of Lead, Phthalates, Bisphenol A( BPA) and other chemicals,

Pacifiers which have teats or nipples made of plastics and rubber has chances of posing risks

related migration of elements. For pacifiers made of plastics, one of the most recent

concerns is the presence of endocrine disrupting substances or compound namely

1 United States Consumer Product Safety Commission - USCPSC

Malaysian Association of Standards Users

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phthalates and bisphenol A (BPA). Other elements are heavy metals such as Plumbum (Pb

or Lead), Arsenic (As) and Mercury (Hg).

For rubber nipples and teats, there may be a release of volatile, non- volatile and other

compounds such as nitrosamines.

2.2. Volatile Nitrosamines and Non- Volatile Nitrosamines

A nitrosamine is an organic substance formed by a specific reaction of two nitrogen

containing substances one of which is an amine (such as a protein for example). The second

nitrogen containing material is called a nitrosating agent such as nitrites used as food

preservatives (particularly in lunch meats).

Many Nitrosamines have been found to be carcinogens when tested at high levels in

animals, and the FDA has recognized that Nitrosamines have been shown to be capable of

penetrating the skin

Volatile N-nitrosamines are potent carcinogens. A research that was conducted showed that

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 U.S regulations, 37.5% of the products would be banned. The article

also explained that one-third of the samples that contained nitrosamines in the rubber

nipples may migrate into the milk within few hours and transfer into saliva is even faster.

Nitrosamines are used in manufacture of some cosmetics, pesticides, and in most rubber

and latex products. Another research on Non – Volatile Nitrosamines was conducted on

baby bottle nipples and pacifiers. Eighteen out of twenty four samples analyzed were found

to contain varying levels of N-nitrosodibenzylamine and it is also known as carcinogenic

compound2 3.

2.3. Design, safety features and labeling

• Pacifiers detaching from the holder

• Protrusion, Strings, Cord, Ribbons, Chain, overall design flaw

• Small parts/ design of shield and guards in the pacifier

• Labeling ( do not tie pacifiers around the neck)

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 3 Determination of non-volatile N-nitrosamines in baby bottle rubber nipples and pacifiers by high-performance

liquid chromatography-thermal energy analysis. Sen NP, Seaman SW, Kushwaha SC.- Pub Med


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2.4. Mandatory Standards and Regulatory Requirement

At the moment UP CPSC has set the limit for nitrosamines in nipple not exceeding 20ppb of

total nitrosamines.

Denmark has set the following limits for migration of elements from soothers or pacifiers:

Table 1: Limits for Elements in Danish Standards – based on EN 71-3

Element Limit ( mg/kg) ppm

Antimony,Sb

Arsenic, As

Barium, Ba

Cadmium, Cd

Lead, Pb

Chromium, Cr

Mercury, Hg

Selenium, Se

15

10

100

20

25

10

10

100

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


N-Nitrosamines

N-Nitrosatables

0.01

0.1

2.5. Malaysian Standard

The MS1156: 1989 Specification for Babies Pacifiers covers pacifiers made of plastics when

tested in accordance with Appendix A ( Extractable antimony arsenic, barium, cadmium,

chromium, lead and zinc) shall not contain (by mass) of soluble antimony arsenic, barium,

cadmium, chromium, lead or zinc or any of their soluble compounds in excess of the

following limits:

Table 2: Limits for Elements in Malaysian Standards: MS1156: 1989 Specification for Babies

Pacifiers


Antimony,Sb

Arsenic, As

Barium, Ba

Cadmium, Cd

Chromium, Cr

Lead, Pb

250

100

500

100

250

100


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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 15ppb of any one volatile nitrosamine when determine accordance

with MS 1312:1993 Method of test for determination of Volatile Nitrosamines in rubber

teats for feeding bottles and babies pacifiers- Dichloromethane Extraction Method.

The MS 1159-1989 is considered to be outdated and it does not cover other important

parameters such as BPA, phthalates etc to be tested.

2.6. Standards Available for Pacifiers, Teats, Nipples, Dummies, Soothers

Table 3: Status of Regulations and Availability of Standards Related to Pacifiers

No Country Standards Available Status of

Regulation

1 Malaysia MS1156: 1989 Specification for Babies

Pacifiers

MS 1312:1993 Method of test for

determination of Volatile Nitrosamines in

rubber teats for feeding bottles and babies

pacifiers- Dichloromethane Extraction

Method

Not

regulated

2 Australia Article I. AS 2432-2009 – Baby

Dummies

Mandatory

3 New

Zealand

Information not available Information

not available

4 Canada Hazardous Products (Pacifiers) Regulations. Mandatory

5 Denmark GPSD Regulation on nitrosamines EN 12868-

Methods for determining the release of N-

Nitrosamines and N-Nitrosatable substances

from elastomer or rubber teats and soothers.

Soothers EN 14060

DS/EN 1400-3 Soothers for Babies and

Yourng Children Part 3 Chemical

Requirements and Test

Mandatory

7 Fiji Trade Standards and Quality Control Decree

Plasticizer known as phthalate IS BANNED in

any toy and child care items

Mandatory

8 US ASTM F1313 - 90(2011) Standard

Specification for Volatile N-Nitrosamine

Levels in Rubber Nipples on Pacifiers

Mandatory


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3. Testing Pacifiers and Sippy Cups for BPA and Volatile Nitrosamines

During a study on baby products in Malaysia and availability of safety standards and

regulations, Standards Users discovered that the US CPSC regulates nitrosamines in baby

pacifiers otherwise known as soothers in the United States and that there were recent

recalls of pacifiers due to content of nitrosamines exceeding the limits set by USCPSC.

Malaysia just recently imposed ban on BPA in plastic feeding bottles (which takes effect in

March 2012) but not sippy cups which are used for children. The above two situations

prompted Standards Users to test pacifiers and sippy cups for nitrosamines and BPA

respectively.

Plastics are also known to pose hazards from the presence phthalates. Presence of all three

substance in pacifiers and sippy cups were determined in the samples purchased.

3.1. Methodology

The following samples were purchased for testing at accredited laboratories.

3.2. 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.


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Anakku Symmetrical

Soother

Asia Brands Global Sdn.Bhd Lot

10449,Jalan Nenas,Batu 4

1/2,Kampung Jawa, 41000 Klang,

Selangor, Malaysia

OK Baby Silicone Baby

Pacifiers

Lita Brights Sdn.Bhd PT 43701,

Jalan BP7/16, 47100 Bandar Bukit

Puchong

3.3. Samples Purchased


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Fiffy Baby Soother Ekspres T.H. Snd Bhd 8, Jalan

Bukit 5, Kws Perindustrian MEIL,

Bandar Seri Alam, 81750 Masai,

Johor, Malaysia

Fiffy Silicone

Soother

Ekspres T.H. Snd Bhd 8, Jalan

Bukit 5, Kws Perindustrian MEIL,

Bandar Seri Alam, 81750 Masai,

Johor, Malaysia


8

Pureen

Basic

Silicone

Soother

with Cover

Summit Co (M) Sdn Bhd Lot

6, Jalan 19/1, 46300 Petaling

Jaya, Selangor

Baby Kiko BPA Free

Silicone

Pacifier-

Orthodontic

Nipple

Baby Kiko Sdn.Bhd No 1,

Jalan Industri PBP 13, Taman

Industri Pusat Bandar

Puchong 47100 Puchong,

Selangor


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OK Baby Sippy Cup Supplier / Manufacturer

Contact NA

Pureen 3 in 1

Nurshing

Cup

Summit Co (M) Sdn Bhd Lot

6, Jalan 19/1, 46300 Petaling

Jaya, Selangor


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Table 4: List of Products Purchased for Testing and their Descriptions

No Brand Product Name Imported/Distributed Barcode Place of

Purchase

Price Per

Unit

Parameter to be

Tested

1 Anakku Symmetrical

Soother

Asia Brands Global

Sdn.Bhd Lot

10449,Jalan

Nenas,Batu 4

1/2,Kampung Jawa,

41000 Klang, Selangor,

Malaysia

9557122347540 Tesco

Selayang

RM 5.90 BPA,Nitrasamine,

Phthalates

2 OK Baby Silicone Baby

Pacifiers

Lita Brights Sdn.Bhd

PT 43701, Jalan

BP7/16, 47100 Bandar

Bukit Puchong

9555103821515 Tesco

Selayang


Phthalates

3 Fiffy Baby Soother Ekspres T.H. Snd Bhd

8, Jalan Bukit 5, Kws

Perindustrian MEIL,

Bandar Seri Alam,

81750 Masai, Johor,

Malaysia

9555121601229 Tesco

Selayang


Phthalates

4 Fiffy Silicone

Soother

Ekspres T.H. Snd Bhd

8, Jalan Bukit 5, Kws

Perindustrian MEIL,

Bandar Seri Alam,

81750 Masai, Johor,

Malaysia

9555121600192 Tesco

Selayang


Phthalates


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No Brand Product Name Imported/Distributed Barcode Place of

Purchase

Price Per

Unit

Parameter to be

Tested

5 Pureen

Basic

Silicone

Soother with

Cover

Summit Co (M) Sdn

Bhd Lot 6, Jalan 19/1,

46300 Petaling Jaya,

Selangor

OOOOO19703167 Tesco

Selayang


Phthalates

6 Baby Kiko BPA Free

Silicone

Pacifier-

Orthodontic

Nipple

Baby Kiko Sdn.Bhd No

1, Jalan Industri PBP

13, Taman Industri

Pusat Bandar Puchong

47100 Puchong,

Selangor

OOOOO19805472 Tesco

Selayang


Phthalates

7 OK Baby Sippy Cup NA 9555103801784 Tesco

Selayang


Phthalates

8 Pureen 3 in 1

Nurshing Cup

Summit Co (M) Sdn

Bhd Lot 6, Jalan 19/1,

46300 Petaling Jaya,

Selangor

9556123108273 Tesco

Selayang


Phthalates


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4. Results

Two laboratories were selected for the testing:

1. ALS Technichem for phthalates and nitrosamines

2. SUCXeS – Shimadzu-UMMC Centre for Xenobiotics Studies for bisphenol A

Figure 1: Lab Report on Phthalates and Nitrosamines Testing


- 13 -

Table 5: Test Results

Baby Pacifiers and Sippy Cup Samples

No Brand Product

Name

Imported/Distributed Barcode Place of

Purchase

Nitsoamine Limit

of Reference

(LOR) = 0.5 and 1

mg/kg

Phthalates:

Limit of

Reference

(LOR) = 0.5

and 5 mg/kg

BPA Limit of

Detection =

0.5ng/ml

1 Anakku Symmetrical

Soother

Asia Brands Global

Sdn.Bhd Lot 10449,Jalan

Nenas,Batu 4

1/2,Kampung Jawa,

41000 Klang, Selangor,

Malaysia

9557122347540 Tesco

Selayang

ND ND ND

2 OK Baby Silicone Baby

Pacifiers

Lita Brights Sdn.Bhd PT

43701, Jalan BP7/16,

47100 Bandar Bukit

Puchong

9555103821515 Tesco

Selayang

ND ND ND

3 Fiffy Baby Soother Ekspres T.H. Snd Bhd 8,

Jalan Bukit 5, Kws

Perindustrian MEIL,

Bandar Seri Alam, 81750

Masai, Johor, Malaysia

9555121601229 Tesco

Selayang

ND ND ND

4 Fiffy Silicone

Soother

Ekspres T.H. Snd Bhd 8,

Jalan Bukit 5, Kws

Perindustrian MEIL,

Bandar Seri Alam, 81750

Masai, Johor, Malaysia

9555121600192 Tesco

Selayang

ND ND ND

5 Pureen

Basic

Silicone

Soother with

Cover

Summit Co (M) Sdn Bhd

Lot 6, Jalan 19/1, 46300

Petaling Jaya, Selangor

OOOOO19703167 Tesco

Selayang

ND ND ND


- 14 -

Baby Pacifiers and Sippy Cup Samples

No Brand Product

Name

Imported/Distributed Barcode Place of

Purchase

Nitsoamine Limit

of Reference

(LOR) = 0.5 and 1

mg/kg

Phthalates:

Limit of

Reference

(LOR) = 0.5

and 5 mg/kg

BPA Limit of

Detection =

0.5ng/ml

6 Baby Kiko BPA Free

Silicone

Pacifier-

Orthodontic

Nipple

Baby Kiko Sdn.Bhd No 1,

Jalan Industri PBP 13,

Taman Industri Pusat

Bandar Puchong 47100

Puchong, Selangor

OOOOO19805472 Tesco

Selayang

ND ND ND

7 OK Baby Sippy Cup NA 9555103801784 Tesco

Selayang

ND ND ND

8 Pureen 3 in 1

Nurshing Cup

Summit Co (M) Sdn Bhd

Lot 6, Jalan 19/1, 46300

Petaling Jaya, Selangor

9556123108273 Tesco

Selayang

ND ND ND


- 15 -

5. Discussions and Recommendations

Although the test reports indicate that the products tested are well within requirements of

safety standards, the MS1156: 1989 Specification for Babies Pacifiers is way overdue for a

review.

The limits for element are not updated according to recent developments which lead to the

revision of the requirements for migration of elements.

Standards Users will raise a request to the Department of Standards Malaysia to revise the

MS 1156: 1989 Specification for Babies Pacifiers.

Currently the Ministry of Health has issued a ban on BPA in plastic feeding bottles effective

March 2012. However, we are concerned that at this point the ban does not cover:

1. Pacifiers

2. Sippy cups

3. Nipples (replacements for damaged or old nipples for feeding bottles)

4. Teethers

5. Food receptacles for infants and their cutlery such as spoons etc.

The amendment to the regulations also does not include nitrosamines and phthalates in the

above list of articles for infants and children. We urge the Ministry of Health to include all

infant food and beverage receptacles in the Food Regulations 1985 with specifications for

phthalates, BPA and heavy metals.

We also urge the relevant government agencies – preferably the Ministry of Domestic

Trade, Cooperatives and Consumerism to regulate all infant / baby products or those

intended to be used for babies / infants which covers products other than food and

beverage receptacles.

new 1. background and introduction - totalweb! lite · 2017. 3. 29. · comparative testing : baby...

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