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Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users
1
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
2
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
Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users
3
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
Element Limit ( mg/kg) ppm
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
Element Limit ( mg/kg) ppm
Antimony,Sb
Arsenic, As
Barium, Ba
Cadmium, Cd
Chromium, Cr
Lead, Pb
250
100
500
100
250
100
Malaysian Association of Standards Users
4
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
Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users
5
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.
Malaysian Association of Standards Users
6
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
Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users
7
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
Malaysian Association of Standards Users
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
Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users
9
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
Malaysian Association of Standards Users
10
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
RM 5.90 BPA,Nitrasamine,
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
RM 4.50 BPA,Nitrasamine,
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
RM 5.90 BPA,Nitrasamine,
Phthalates
Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users
11
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
RM 2.70 BPA,Nitrasamine,
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
RM 6.90 BPA,Nitrasamine,
Phthalates
7 OK Baby Sippy Cup NA 9555103801784 Tesco
Selayang
RM 4.50 BPA,Nitrasamine,
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
RM 7.60 BPA,Nitrasamine,
Phthalates
Malaysian Association of Standards Users
12
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
Comparative Testing : Baby Pacifier and Sippy Cups Malaysian Association of Standards Users
- 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
Malaysian Association of Standards Users
- 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
Malaysian Association of Standards Users
- 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.