ASTM F3159-15(2022)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3159 −15 (Reapproved 2022)
Standard Safety Specification for
Liquid Laundry Packets
This standard is issued under the fixed designation F3159; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
In November 2012, the U.S. Consumer Product Safety Commission (CPSC) issued a SafetyAlert
to inform parents and caregivers that Liquid Laundry Detergent Packets need to be kept away from
children as those who are exposed to packet contents are at risk of serious injury and even death due
to the highly concentrated nature of the product. Children who have accidently ingested Liquid
Laundry Detergent Packets have experienced a range of injuries including loss of consciousness,
respiratory distress, vomiting, coughing, choking and drowsiness, and in cases where there has been
contactwiththeeyes,painfulirritationoftheeyesandcornealburnshaveoccurred.Inaddition,death
hasbeenreportedtooccurfollowingingestionofLiquidLaundryDetergentPackets,includinginone
child.
1. Scope 2. Referenced Documents
2.1 ASTM Standards:
1.1 This specification provides requirements for household
D3475Classification of Child-Resistant Packages
Liquid Laundry Detergent Packet safety to help reduce unin-
D4332Practice for Conditioning Containers, Packages, or
tentionalexposurestothecontentsofthepackets,especiallyto
Packaging Components for Testing
children.
D4359Test Method for Determining Whether a Material Is
1.2 This standard applies exclusively to household Liquid
a Liquid or a Solid
Laundry Detergent Packets. “Liquid Laundry Detergent Pack-
2.2 ANSI Standard:
ets” are single-use laundry detergent products that contain a
ANSI Z535.4Safety Color Code—Environmental Facility
liquiddetergentenclosedinawatersolubleouterlayer(“pouch
Safety Signs—Criteria for Safety Symbols—Product
film”). This includes laundry detergent packets in soluble film
Safety Sign and Labels and Accident Prevention Tags
thatcontainliquidonly(thatis,allliquid),aswellasthosethat
3. Terminology
contain both liquid and non-liquid components.
3.1 Definitions:
1.3 This standard does not purport to address all of the
3.1.1 liquid, n—a substance or mixture which: (1) at 50°C
safety concerns, if any, associated with its use. It is the
has a vapour pressure of not more than 300 kPa (3 bar), (2)
responsibility of the user of this standard to establish appro-
which is not completely gaseous at 20°C and at a standard
priate safety, health, and environmental practices and deter-
pressure of 101.3 kPa, and (3) which has a melting point or
mine the applicability of regulatory limitations prior to use.
initial melting point of 20°C or less at a standard pressure of
1.4 This international standard was developed in accor-
101.3 kPa.
dance with internationally recognized principles on standard-
3.1.1.1 Discussion—A viscous substance or mixture for
ization established in the Decision on Principles for the
which a specific melting point cannot be determined shall be
Development of International Standards, Guides and Recom-
subjected to theTest Method D4359 – 90 test; or to the test for
mendations issued by the World Trade Organization Technical
determining fluidity (penetrometer test) prescribed in section
Barriers to Trade (TBT) Committee.
2.3.4 of Annex A of the European Agreement concerning the
International Carriage of Dangerous Goods by Road (ADR).
1 2
This specification is under the jurisdiction of ASTM Committee F15 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Consumer Products and is the direct responsibility of Subcommittee F15.71 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Liquid Laundry Packets. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved March 1, 2022. Published March 2022. Originally theASTM website.
ɛ1 3
approved in 2015. Last previous edition approved in 2015 as F3159–15 . DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F3159-15R22. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3159 − 15 (2022)
3.1.2 liquid laundry detergent packets, n—individual pack- 5.3 Options for Packaging:
ets that contain liquid laundry detergent and are intended to 5.3.1 Apackagethatmeetstheperformancerequirementsof
dissolve when used as intended. 16CFRPart1700,section1700.15andtestingrequirementsof
16 CFR Part 1700, section 1700.20.
3.1.3 pouch film, n—the water-soluble outer layer of a
5.3.2 An individually-wrapped package that contains no
Liquid Laundry Detergent Packet that contains laundry deter-
more than one packet and incorporates either:
gent or other liquid ingredients, or both, and is designed to
5.3.2.1 Ahiddentabornotchorothermeansofopeningthat
dissolve when used as intended.
is only exposed after the package has been folded or manipu-
4. Liquid Laundry Detergent Packet Requirements lated in an instructed manner, or
5.3.2.2 A feature described in Classification D3475 – 14,
4.1 The Liquid Laundry Detergent Packet must meet the
Type IV Non-reclosable packaging-flexible and Type V Unit
requirements set forth in European Commission Regulation
non-reclosable packaging-rigid.
(EU) No 1272/2008, Annex II, Part 3, Section 3.3.3, and
5.3.3 Apackagethatrequiresmanipulativeskillordexterity
Sections4(AversiveAgentintheSolubleFilm)and5(Capsule
to open, including, but not limited to:
Integrity) of the accompanying AISE Liquid Laundry Deter-
4 5.3.3.1 A package with two or more closure mechanisms
gent Capsules Guidelines on CLP Implementation , including
that are interdependent, so that the package cannot be fully
as may be amended. For reference, EU No 1272/2008,Annex
opened without releasing at least two of the closure mecha-
II, Part 3, Section 3.3.3, is attached as AnnexA5, and Sections
nisms.
4 and 5 of the AISE Liquid Laundry Detergent Capsules
5.3.3.2 A double-action release mechanism, defined as ei-
Guidelines on CLPImplementation are attached as AnnexA7.
ther:
4.2 For the avoidance of doubt, European Commission
(1)A mechanism requiring two consecutive motions, the
Regulation(EU)No1272/2008,AnnexII,Part3,Section3.3.3
first of which must be maintained (and which may include the
(i) does not specify any particular manner in which the soluble
act of physically holding or stabilizing the package) while the
packaging containing the agent must have the aversive agent
second is carried out in order to fully open the package, or
added to the soluble packaging. A company may choose, by
(2)Two separate and independent motions that must be
way of non-limiting examples, to introduce the aversive agent
activated or occur simultaneously to fully open the package.
to the soluble packaging by admixing it into a slurry that is
NOTE 1—Asimple zipper closure (pull to open or simple slider) would
subsequently formed or cast into a film and/or by coating it
not meet the requirements of either 5.3.3.2(1) or (2).
onto a previously formed film. It is up to each company to
5.3.3.3 A release mechanism or system of mechanisms
selecttheaversiveagentandtechnologytheydeemappropriate
which requires two independent release mechanisms to be
fortheirproductsandeffectiveformeetingthecriteriaofbeing
performed consecutively in order to fully open the package.
safe and eliciting oral repulsive behavior within a maximum
5.3.3.4 The package must be designed so that the user is
time of6sas provided by and in accordance with the EU
able to close the package and re-engage the release mecha-
Regulation.
nism(s) in a manner that requires only one re-engagement
5. Packaging Requirements
action on the part of the user.
5.3.4 A package closure that meets the requirements set
5.1 Liquid Laundry Detergent Packets shall be contained in
forth in European Commission Regulation (EU) No 1272/
opaque packaging or packaging that employs any equivalent
2008, Annex II, Part 3, Section 3.3.2 (iv), and Section 3.3
measureintendedtomaskthevisibilityoftheindividualLiquid
(OuterPackaging:Closures)oftheaccompanyingAISELiquid
Laundry Detergent Packets (“Package” or “Packaging”). The
Laundry Detergent Capsules Guidelines on CLP
package must not be labeled with graphics that make the
Implementation, as may be amended. For reference, EU No
opaque package appear transparent or translucent.
1272/2008, Annex II, Part 3, Section 3.3.2 (iv), is attached as
5.2 Packaging described in this Voluntary standard is pack-
Annex A4, and Section 3.3 of the AISE Liquid Laundry
agingthatisdesignedorconstructedtobedifficultforchildren
Detergent Capsules Guidelines on CLP Implementation is
to access Liquid Laundry Detergent Packets. To comply with
attached as Annex A6.
this standard, the package shall have the characteristics of at
5.3.5 Apackage that requires the intellectual skill or cogni-
least one of the following six options outlined below in 5.3.1.
tive ability of a child at least 6 years of age to open, that meets
In addition to meeting with at least one of the six options, a
all of the criteria set forth in 5.3.5.1 – 5.3.5.3, or a reasonable
package must also:
equivalent of 5.3.5.1 – 5.3.5.3, and meets the requirements of
5.2.1 Comply with this standard through the full life cycle
5.3.5.4:
of product package.
5.3.5.1 Identification of a non-obvious opening method that
5.2.2 The package must meet the option standard for which
requires cognitive understanding of a manipulative concept.
the package is designed while also accounting for any other
5.3.5.2 The mechanical means that secures the package is
way the package could conceivably be opened for example by
obscured from view and not readily apparent when handling
twisting, pulling, or use of singular force.
the package.
5.3.5.3 Requires manipulation of a visual or tactile feature
in a way that is non-obvious unless the user understands the
A.I.S.E., Liquid Laundry Detergent Capsules Guidelines On CLP
Implementation, Version 1.0, 27 February 2015. manipulative concept.
F3159 − 15 (2022)
5.3.5.4 The package must be designed so that the user is Packets can burst if children put them in mouth or play with
able to close the package and re-engage the release mecha- them.
nism(s) in a manner that requires only one re-engagement
See warning on [back/side] label.
action on the part of the user.
Keep out of reach of children.
5.3.6 Apackage that, in order to be opened, requires either:
6.2.1 See AnnexA1 for an example of an FHSA-compliant
(1)An opening force greater than that which a child is
layout.
capable of generating while not being greater than a senior
6.3 The Safety Alert Symbol and text of the precautionary
adult is capable of generating, or
statements shall be laid out on the back or side panel of the
(2)Hand anthropometric characteristics greater than those
secondary container as set forth in ANSI Z535-4 (2011)
of an average-sized child.
Figures 3 through 12 and Figures B26 through B28 or in a
5.3.6.1 Theagesanddistributionofchildrentobetestedfor
substantiallysimilarformat,exceptthatneitherthebordersnor
purposes of establishing the opening force strength or hand
boxesdepictedinthosefiguresarerequired.Theprecautionary
anthropometric characteristics must meet the requirements set
statements shall include the following:
forth in 16 CFR 1700.20(a)(2)(i).
6.3.1 The Safety Alert Symbol, as found in ANSI Z535-4,
5.3.6.2 The opening force strength or hand anthropometric
Fig. 1 (D) or (E).
characteristics shall be set at the 95th percentile for children,
6.3.2 Annex A2 includes additional safety symbols to be
and the 5th percentile for senior adults.
used with the warning statements. Each package must feature
5.3.6.3 Research must demonstrate that the opening force
at least one pair (that is, one “keep out of reach of children”
strength or hand anthropometric characteristics do not exceed
symbol and one “keep contents out of eyes” symbol).
those of senior adults between the ages of 50 and 70 years to
access the package, as tested pursuant to the requirements set
6.4 The following statements shall appear on the back or
forth in 16 CFR 1700.20(a)(3).
side panel of the secondary container:
5.3.6.4 Research that establishes opening strength or hand
WARNING:
anthropometric characteristics as set forth above must be
Concentrated detergent packets can burst if children put
conducted by an independent third party, and the results
them in mouth or play with them. The liquid inside is
published in a peer-reviewed journal.
harmful if put in mouth, swallowed, or in eyes.
5.3.6.5 A manufacturer must demonstrate through testing
Keep packets out of reach of children.
that the opening force required or hand anthropometric char-
• Storecontainerwherechildrencannotreachorclimbtoit,
acteristics for its packaging design are within the limits of the
out of sight and in a secure place.
data.
• Keep container fully closed.
• Never leave any packets out of container.
6. Labels
• DO NOT let children handle packets, even if supervised.
6.1 Each package shall be labeled with warning statements.
Avoid breaking packets.
The warning statements shall be:
• Do not handle packets with wet or moist hands. Do not
6.1.1 In contrasting color(s), permanent, conspicuous, and
expose packets to moisture.
in sans serif style font;
• Do not cut or puncture packets. If packets stick together,
6.1.2 Distinctively separated from any other wording or
do not try to separate them.
graphics, in a “quiet zone” (that is, placed on a single-color,
Call poison control center immediatelyifdetergentgetsin
contrasting background); and
mouthoreyeoronskin.Immediatelyandthoroughlyrinseeye
6.1.3 Locatedontheproductinaprominentlocationsothey
or skin with water for 15 min.
are visible to the consumer.
6.5 Allindividually-wrappedsamplepackagesshallcontain
6.2 The following statements shall appear on the front
no more than one packet. Each individually-wrapped sample
panel/principal display panel of the package:
package shall include the following statements:
WARNING:
Harmful if put in mouth or swallowed. Eye irritant. WARNING:
FIG. 1 Safety Alert Symbol
F3159 − 15 (2022)
Concentrated detergent packets can burst if children put “keepoutofreachofchildren”symbolandone“keepcontents
them in mouth or play with them. The liquid inside is out of eyes” symbol) of the additional safety symbols from
harmful if put in mouth, swallowed, or in eyes. Annex A2.
Keep packet out of reach of children.
6.7 ThelanguagelistedaboveandiconsshowninAnnexA2
• Store where children cannot reach or climb to it, out of
may be modified as necessary to ensure compliance with local
sight and in a secure place.
regulatoryrequirements,orfortranslationpurposes.Additional
• DO NOT let children handle packet, even if supervised.
warnings or cautionary statements or, if appropriate, alternate
• Use packet immediately after opening.
first aid instructions may also be included on the label,
Avoid breaking packet.
depending on the formula, packaging used and other consid-
• Do not handle packet with wet or moist hands. Do not
erations. Furthermore, and for the avoidance of doubt, other
expose packet to moisture.
words, such as “pac” or “pack” or a trademarked name for the
• Do not cut or puncture packet.
product,maybesubstitutedfor“packets”inthesestatementsin
Call poison control center immediatelyifdetergentgetsin
order to allow for consistent terminology on each product’s
mouthoreyeoronskin.Immediatelyandthoroughlyrinseeye
package.
or skin with water for at least 15 min.
7. Keywords
6.6 Each individually-wrapped packet that is contained in a
larger outer package that contains multiple individually- 7.1 child deterrent; container; detergent; ingestion; laundry
wrapped packets shall include at least one pair (that is, one packet
ANNEXES
(Mandatory Information)
A1. FHSA-COMPLIANT PRINCIPAL DISPLAY PANEL (FRONT PANEL)
WARNING: HARMFUL IF PUT IN MOUTH OR SWAL- Keep out of reach of children.
LOWED. EYE IRRITANT. Packets can burst if children put
them in mouth or play with them. See warning on [back/side]
label.
A2. ICON AND ALERT SYMBOL EXAMPLES
A2.1 See Fig. A2.1.
F3159 − 15 (2022)
NOTE 1—If words are not included within the prohibition surround shape, use standard prohibition circle (rather than the version that is widened to
accommodate words, as seen in the first example).
FIG. A2.1 Icon and Alert Symbol Examples
F3159 − 15 (2022)
A3. OTHER INFORMATION SOURCES RELATING TO THE SAFETY OF LIQUID LAUNDRY DETERGENT PACKETS
ACCC, http://www.productsafety.gov.au/content/index. AISE (Europe), http://www.aise.eu/go.php?pid=44122
phtml/itemId/999447 & http://www.productsafety.gov.au/ &topics=1
content/index.phtml/itemId/998653/fromItemId/999447
CPSC (USA), http://www.cpsc.gov//PageFiles/132488/
Accord, http://www.accord.asn.au/public_information_
390%20Laundry%20Packets.pdf
submission/children_and_safe_storage
ACI (USA), http://www.cleaninginstitute.org/clean_living/
singleload_liquid_laundry_packets.aspx
A4. EUROPEAN COMMISSION REGULATION (EU) NO 1272/2008, ANNEX II, PART 3, SECTION 3.3.2(iv)
A4.1 Without prejudice to the requirements of section 3.1, children to open it; (b) maintains its functionality under
be fitted with a closure that: (a) impedes the ability of young conditions of repeated opening and closing for the entire life
childrentoopenthepackagingbyrequiringcoordinatedaction
span of the outer packaging.
of both hands with a strength that makes it difficult for young
A5. EUROPEAN COMMISSION REGULATION (EU) NO 1272/2008, ANNEX II, PART 3, SECTION 3.3.3
A5.1 The soluble packaging shall: A5.1.2 Retain its liquid content for at least 30 s when the
soluble packaging is placed in water at 20°C;
A5.1.1 Contain an aversive agent in a concentration which
is safe, and which elicits oral repulsive behaviour within a A5.1.3 Resist mechanical compressive strength of at least
maximum time of 6 s, in case of accidental oral exposure; 300 N under standard test conditions.
A6. A.I.S.E. LIQUID LAUNDRY DETERGENT CAPSULES GUIDELINES ON CLP IMPLEMENTATION (SECTION 3.3)
A6.1 Closures standingisthattheclosurerequirementsforSolublePackaging
are different from child-resistant fastenings in section 3.1 and
A6.1.1 TheclosureoftheLLDCouterpackagingmustmeet
apply independently, without conflict. So section 3.1 ofAnnex
two main requirements that need to be balanced:
II continues to apply for certain mixture classifications and, in
A6.1.1.1 impede young children from opening the packag-
addition, the new section 3.3 applies to LLDCs regardless of
ing and
their classification.
A6.1.1.2 for adults, allow easy regular opening and reclos-
A6.1.6 No performance standards exist today for ‘child-
ing after use.
impeding closures’ that are not fully ‘child-resistant’ (in the
A6.1.2 These functionalities must be maintained during the
meaning of the ISO 8371 standard). Our industry is committed
packaging life span.
to work on the development of a performance standard to
A6.1.3 Inaddition,thepack(thatis,the‘outerpackaging’in
assess the ‘child-impeding’function of packaging, taking into
theSolublePackagingRegulation)shouldbeself-standingand
account that ‘coordinated action of both hands’is required.
should remain so throughout the life span of the pack.
A6.1.7 It should be noted that it would require at least two
A6.1.4 Withregardtoclosuredesign,theSolublePackaging
years to shelf new packaging designs in all markets.
Regulation refers qualitatively to two elements: ‘requiring
A6.1.8 In the meantime, A.I.S.E. suggests the following:
coordinated action of both hands’and ‘a strength’for opening.
A6.1.8.1 ‘coordinated action of both hands’for opening: in
A6.1.5 These requirements apply ‘without prejudice to the the lack of clear design description in the legal text, it is up to
requirements of section 3.1 [of Annex II to CLP]’ which eachcompanytoassessthedesignagainstcompliancewiththis
prescribe child-resistant fastenings for specific mixture classi- general requirement. It builds on the fact that the key differ-
fications (such as skin corrosive products). A.I.S.E.’s under- entiator between adults and children is mental capacity, logic
F3159 − 15 (2022)
and dexterity. Coordination may include the required use of A6.1.8.3 ‘easily reclosable’: the outer packaging closure
hands to secure a pack to enable the opening of a closure must be able to be closed by adults in a single action, such as
system (for example, stand-up pouches).
but not limited to, one clip to be pushed, a gentle pressure on
A6.1.8.2 ‘with a strength’ for opening: is to be seen in the
the lid to lock, one zipper to be activated.
context of the target age group, namely children below the age
A6.1.8.4 ‘maintains its functionality under conditions of
of 6 years. No strength value is specified in the legal text but
repeated opening and closing for the entire life span’: the
it should be sufficient so that the closure cannot be opened
closure system must meet the above criteria on opening and
unintentionally (for example, by simply touching the outer
reclosing for the designed life of the packaging, which corre-
packaging). Again, it should be borne in mind that the key
spondstoatleastthenumberofcapsules/unitdosesintheouter
differentiatorbetweenadultsandchildrenisdexterityandlogic
packaging.
rather than strength.
A7. A.I.S.E. LIQUID LAUNDRY DETERGENT CAPSULES GUIDELINES ON CLP IMPLEMENTATION (SECTIONS 4 AND 5)
A7.1 Aversive Agent in the Soluble Film nella et al. (2005) . Consequently, it is reasonable to assume
that the observed oral rejection times with young adults are
A7.1.1 According to the Soluble Packaging Regulation, the
similar to or higher than what may be expected with young
soluble packaging (that is, the capsule wall) must contain an
children.
aversive agent in a concentration which is safe, and which
A7.1.8 It is important to note that it is up to each company
elicits oral repulsive behavior within a maximum time of 6 s,
to demonstrate effectiveness of the aversive agent chosen to
in case of accidental oral exposure.
theirownsituation(solublefilm/agents)at designstage.Thisis
A7.1.2 This measure is intended to further reduce the
because:
chance of ingestion of the liquid content in case a child left
A7.1.8.1 different aversive agents may lead to different
unattended has managed to gain access to a capsule and places
human responses and
it in his/her mouth.
A7.1.8.2 the effective concentration of aversive agent may
be affected by the polymer chemical composition, presence of
A7.1.3 A.I.S.E. has developed and evaluated a protocol to
other chemicals in the film, etc.
determine effective levels of aversive agent contained in
soluble packaging, that is, in the soluble film. The resulting A7.1.9 It is also up to each company to select the aversive
study protocol is provided in Annex A8. agent they deem appropriate for their products, taking into
account that some limitations of use related to Intellectual
A7.1.4 The objectives of this work were:
Property may apply to certain aversive agents, films or tech-
A7.1.4.1 to develop a method for measuring the oral rejec-
nologies.
tion time, as a function of the level of aversive agent in the
A7.1.10 It is advised to foresee a safety margin so that the
film;
effectiveness of the aversive agent is maintained during the
A7.1.4.2 to prove the concept of effectiveness testing (at
whole life cycle of the product.
different concentrations of aversive agent), in other words to
A7.1.11 Companies will need to document the levels of
establish a ‘benchmark test’.
aversive agent used and the rationale, and keep such records
A7.1.5 One grade of film and one particular aversive agent
for 10 years (in line with the general REACH and CLPrecord
were selected for the study.
keeping deadlines).
A7.1.6 TheA.I.S.E. study has shown that, for the particular A7.1.12 Further, the Soluble Packaging Regulation requires
aversiveagentandfilmselected,itwaspossibletodeterminea the effective concentration of aversive agent to be safe.
level of aversive agent sufficient to elicit a median oral A.I.S.E. recommends to determine that the concentration
rejection in less than 6 s. Above this concentration, the chosen is safe in case of ingestion of the amount of film
‘dose-response’curvewasflat,thatis,higherlevelsofaversive contained in one capsule, by means of a human health
toxicological risk assessment, based on the highest level of
agent were not found to lead to lower rejection times. A
summary of the study findings is provided in Annex A9. aversive agent contained in the soluble packaging at any time
of the product life cycle and adapted to the target age group
A7.1.7 For ethical reasons, the study was run on young
(youngchildren,includingbabies).Thesafetydatesheetofthe
adults instead of children. This is a conservative approach,
aversive agent is a useful source of toxicological data but may
because a child’s palate is much more sensitive than that of
not be sufficient to run a full risk assessment.
adults. Infants have around 30000 taste buds spread through-
out their mouths. By the time adulthood is reached, only about
Julie A. Mennella, M. Yanina Pepino, and Danielle R. Reed. Genetic and
a third of these remain, mostly on the tongue. The decreasing
environmental determinants of bitter perception and sweet preferences. Pediatrics,
sensitivity to bitterness with age was demonstrated by Men- 2005, 115 (2), e216–e222.
F3159 − 15 (2022)
A7.1.13 Environmental safety should also be documented. A7.2.4 The capsules will be tested at least 24 h after
ItshouldberemindedthattheREACHRegistrationisthemain production after having been conditioned in an environment
mechanism to assess environmental safety of substances and withastandardtemperatureandrelativehumditiy.Moredetails
demonstrate the use is safe (unless a particular substance does areprovidedinthetestprotocols(AnnexA11andAnnexA12).
not need to be registered by law). Annex A10 provides an
A7.2.5 Liquid Containment Function:
example of a screening environmental risk assessment for one
A7.2.5.1 The Soluble Packaging Regulation requires the
particular aversive agent (denatonium benzoate) showing that,
soluble packaging to retain its liquid content for at least 30 s
even under conservative assumptions, the addition of this
when the capsule is in contact with water. Some of the testing
bittering agent in unit dose soluble films is of no concern from
parameters are set by the Regulation (water, temperature).
an environmental perspective.
A7.2.5.2 To A.I.S.E.’s knowledge, no standard method ex-
ists for such type of test.
A7.2 Capsule Integrity
A7.2.5.3 Building on the experience from its members,
A7.2.1 Two specific requirements apply under the Soluble
A.I.S.E. has developed a containment function test protocol,
PackagingRegulationinrelationtocapsuleintegrity:mechani-
which is provided in Annex A11 to this document.
cal resistance and liquid containment.
A7.2.6 Mechanical Integrity:
A7.2.2 Both the mechanical and the containment function
A7.2.6.1 The Soluble Packaging Regulation requires the
tests are understood as ‘design tests’. They serve a safety
soluble packaging to resist a mechanical compression strength
purposeinthequalificationofproducts/validationofprocesses.
of 300 N under standard test conditions.
They are not considered as quality control tests since it is
A7.2.6.2 A.I.S.E. recommends running a dynamometric
impossible in practice to test every single capsule.
test: the purpose of such compression test is to assess the
A7.2.3 These tests should be performed on an appropriate, mechanical integrity of a capsule submitted to a compressive
representative number of capsules at design stage and should strength.
be repeated, at the minimum, at every substantial design A7.2.6.3 Building on the experience from its members,
change in product, film specification, formulation or manufac- A.I.S.E. has developed a test protocol, which is provided in
turing process. Annex A12 to this document.
A8. STUDY PROTOCOL: ASSESSMENT OF THE EFFECTIVENESS OF AN AVERSIVE AGENT IN SOLUBLE FILM FOR
LIQUID LAUNDRY DETERGENT CAPSULES
A8.1 Objective A8.2.4 Each panelist, unaware of what to expect, will be
given a sheet of the soluble film containing a given level of
A8.1.1 The objective of this test is to determine the effec-
aversive agent, and will be asked to lick the film to experience
tiveness of a given aversive agent contained in a given soluble
the taste. It will then be recorded whether the panelist rejects
packaging film. The dose-response relationship of the level of
the film and if so, after how much time. panelists are only
aversive agent with the observed oral rejection time is inves-
allowed to participate once, to avoid any bias due to prior
tigated. From this, the level of aversive agent that is expected
experience with a bad tasting sample.
to lead to a rejection time below6sis determined.
A8.2.5 Aconcentration series will be tested, in two rounds.
A8.2 General Study Description
First, in a screening round, a broad range of levels of aversive
agent in film shall be assessed, as well as an untreated blank.
A8.2.1 The response of test panelists to tasting water-
Subsequently, based on the screening round results, suitable
soluble film with different levels of aversive agent is to be
aversive agent test levels shall be defined for a definitive
observed. From this, a dose-response relationship is to be
testing round, aiming to refine the dose-response relationship
established that links the deterring effect (rejection of the film)
forthoselevelsleadingtoarejectiontimeclosetothetargetof
with the level of the aversive agent.
maximum 6 s.
A8.2.2 The test panel shall consist of young adults, as a
proxy for the target audience for the safety measures on liquid A8.3 Test Material
laundry detergent capsules (that is, young children). There are
A8.3.1 The test material is a combination of one specific
reliable indications that, especially for bitter taste, children are
water-soluble film type with one specific aversive agent, at
usually more sensitive than adults.
different concentration levels. Both the water-soluble film and
A8.2.3 The test product is the water-soluble film containing the aversive agent tested shall be identified in the study report
(different levels of) the aversive agent. The film shall be used and/or in the study sponsor’s confidential study placement
in isolation for tasting: actual detergent capsules shall not be documentation. The results of the study are specific to the
used, to ensure the safety of the panelists. type/gradeofwater-solublefilmandthetype/gradeofaversive
F3159 − 15 (2022)
agent used. Consequently, results cannot be extrapolated to study has been designed to eliminate as much of the adults
substantially different combinations of film and aversive ‘over thinking’ to the test as possible, attempting to gage a
agent . ‘true’reaction time.
A8.4.3 The test panel shall consist of the following indi-
A8.3.2 Preparation of Water-Soluble Film Treated with
Aversive Agent: viduals:
A8.4.3.1 young adults, in the age group of 18-25 years old
A8.3.2.1 Water-soluble films with different levels of the
aversive agent shall be prepared: A8.4.3.2 equal mix male/female
(1)Screening test: untreated (blank) – 10ppm – 100ppm – A8.4.3.3 exclusion criteria:
1000ppm – 10000ppm (*)(**) (1)smokers shall be excluded.
(*) a toxicological safety assessment shall be conducted (2)panelists with prior experience on tests of aversive
prior to the study. if toxicological concerns exist with the agents in this context shall be excluded.
highest screening levels, an alternative concentration series
A8.4.4 Each panelist shall participate to only one single
with lower levels should be used.
tasting session, to avoid a biased response driven by prior
(**) a range with a different upper level may be used if
experience.
pre-existing information suggests this is more appropriate.
(2)Finaltest:6levels(noblank)tobedeterminedbasedon
A8.5 Test Design and Instructions
the outcome of the screening test.
A8.5.1 The test shall be conducted in two rounds:
A8.3.2.2 Accuracyoftheaversiveagent’slevelsinthefilm,
A8.5.1.1 a screening round in which a wide range o
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