EFSA Journal - 2013 - Scientific Opinion On The Safety Evaluation of The Active Substance Acrylic Acid Sodium Salt

EFSA Journal 2013;11(4):3154
SCIENTIFIC OPINION
Scientific Opinion on the safety evaluation of the active substance,

acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester,
methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked for
use in active food contact materials 1
EFSA Panel on Food Contact Materials, Enzymes,
Flavourings and Processing Aids (CEF) 2, 3
European Food Safety Authority (EFSA), Parma, Italy
ABSTRACT
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
deals with the safety evaluation of the acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester,
methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked (CAS No. 117675-55-5, FCM Substance
No 1022), to be used as liquid absorber in the form of fibres in absorbent pads for the packaging of fresh or
frozen meat, poultry, and fish as well as fresh fruits and vegetables. The Panel considered that migration is not
expected when the absorption capacity of the pads is not exceeded. Therefore no exposure from the consumption
of the packed food is expected. The Panel also considered that none of these starting substances and the cross-
linked polymer gives rise to concern for genotoxicity. Therefore the CEF Panel concluded that the use of the
substance acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2
hydroxypropylester, and acrylic acid cross-linked does not raise a safety concern when used as fibres in absorber
pads for the packaging of fresh or frozen meat, poultry, fish, fruits and vegetables under conditions under which
the absorption capacity of the pads is not exceeded and mechanical release of the fibres from the pads is
excluded.
© European Food Safety Authority, 2013
KEY WORDS
Acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2 hydroxypropylester, and
acrylic acid cross-linked, CAS number 117675–55-5; FCM Substance No 1022; Food contact materials; Active
and intelligent materials.
1
On request from the Food Standards Agency, UK, Question No EFSA-Q-2011-00200 and from the Bundesamt für
Verbraucherschutz und Lebensmittelsicherheit, Germany, Question No EFSA-Q-2011-00222, adopted on 19 March 2013.
2
Panel members: Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle,
Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter
Jany, Martine Kolf-Clauw, Catherine Leclercq, Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria
Rosaria Milana, Maria de Fátima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. One member of the
Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest
identified in accordance with the EFSA policy on declarations of interests. Correspondence: cef@efsa.europa.eu
3
Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise
Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi,
Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Karla Pfaff, Maria de Fátima Poças, Philippe
Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.
Suggested citation: EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific
Opinion on the safety evaluation of the active substance, acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester,
methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked for use in active food contact materials. EFSA Journal
2013;11(4):3154. [10 pp.] doi:10.2903/j.efsa.2013.3154. Available online: www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2013

18314732, 2013, 4, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3154 by Lupin Ltd Lupin Research Park, Wiley Online Library on [25/10/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2-
hydroxypropylester, and acrylic acid crosslinked
SUMMARY
According to the Commission Regulation (EC) No 450/2009 4 of the Commission of European
Communities of 29 May 2009 on active and intelligent materials and articles intended to come into
contact with food, substances responsible for the active or intelligent function need first to be
evaluated by EFSA before their inclusion into a positive Community list. The procedure of the
evaluation and the tasks of EFSA are described in the Regulation (EC) No. 1935/2004 5 of the
European Parliament and of the Council of 27 October 2004 on materials and articles intended to
come into contact with food.
In the context of this evaluation procedure following requests from the Food Standards Agency, UK,
and from Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, the Panel on Food
Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was asked to deliver an opinion
on acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2
hydroxypropylester, and acrylic acid cross-linked (CAS number 117675-55-5, FCM substance No
1022) to be used as liquid absorber in the form of fibres in absorbent pads for the packaging of fresh
or frozen meat, poultry, fish, fruits and vegetables. The application dossiers were submitted to the
Member State Authorities by Technical Absorbents Ltd UK and by McAirlaid’s Vliesstoffe GmbH &
Co KG.
Acrylic acid (CAS 79-10-7, FCM Substance No 147) and acrylic acid, methyl ester (CAS 96-33-3,
FCM Substance No 176) are authorised as monomers for plastic materials and articles in contact with
food (Commission Regulation (EU) No 10/2011 6) with a group SML of 6 mg/kg food, expressed as
acrylic acid. Methacrylic acid, 2-hydroxypropyl ester EFSA has been evaluated by the EFSA CEF
Panel for use as monomer in acrylic resin coatings for food cans.
The Panel considered that migration is not expected when the absorption capacity of the pads is not
exceeded. Therefore no exposure from the consumption of the packed food is expected.
The Panel also considered that none of these starting substances give rise to concern for genotoxicity.
Considering this, also the size of the cross-linked polymer and its blocked functional groups and that
it does not induce gene mutations in an adequately performed in vitro genotoxicity test, the Panel
concluded that the cross-linked polymer does not raise concern for genotoxicity.
Therefore the CEF Panel concluded that the use of the substance acrylic acid, sodium salt, co-polymer
with acrylic acid, methyl ester, methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked
does not raise a safety concern when used as fibres in absorbent pads for the packaging of fresh or
frozen meat, poultry, fish, fruits and vegetables under conditions under which the absorption capacity
of the pads is not exceeded and mechanical release of the fibres from the pads is excluded.
4
Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to
come into contact with food. OJ L 135, 30.5.2009, p. 3–11.
5
Regulation (EC) No 1935/2004 of the European parliament and of the council of 27 October 2004 on materials and articles
intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. OJ L 338, 13.11.2004, p.
4–17.
6
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into
contact with food Text with EEA relevance. OJ L 12, 15.1.2011, p. 1–89.
EFSA Journal 2013;11(4):3154 2

TABLE OF CONTENTS
Abstract ......................................................................................................................................................... 1
Summary ....................................................................................................................................................... 2
Table of contents ........................................................................................................................................... 3
Background as provided by the legislation ................................................................................................... 4
Terms of reference as provided by the legislation ........................................................................................ 4
Assessment .................................................................................................................................................... 6
1. Introduction ........................................................................................................................................... 6
2. General information .............................................................................................................................. 6
3. Data available in the dossier used for this evaluation ........................................................................... 7
4. Evaluation .............................................................................................................................................. 7
4.1. Non-toxicological data ............................................................................................................. 7
4.2. Toxicological data .................................................................................................................... 8
Conclusions ................................................................................................................................................... 8
Documentation provided to EFSA ................................................................................................................ 8
References ..................................................................................................................................................... 8
Glossary and abbreviations ......................................................................................................................... 10
EFSA Journal 2013;11(4):3154 3

BACKGROUND AS PROVIDED BY THE LEGISLATION

Commission Regulation (EC) No 450/2009 of the Commission of European Communities is a specific
measure that lays down specific rules for active and intelligent materials and articles intended for
contact with foodstuffs in addition to the general requirements established in Regulation (EC) No
1935/2004 of the European Parliament and of the Council on materials and articles intended to come
into contact with food. Active materials and articles are intended to extend the shelf-life or to
maintain or improve the condition of packaged food; they are designed to deliberately incorporate
components that would release or absorb substances into or from the packaged food or the
environment surrounding the food.
The substance(s) responsible for the active and/or intelligent function of the material should be
included in a positive list by the Commission following a safety evaluation by EFSA according to the
procedure described in the abovementioned regulations.
According to this procedure the industry submits applications to the Member States competent
Authorities which transmit the applications to EFSA for their evaluation. The application is supported
by a technical dossier submitted by the industry following the EFSA “guidelines on submission of a
dossier for safety evaluation by the EFSA of active or intelligent substances present in active and
intelligent materials and articles intended to come into contact with food” (EFSA, 2009).
In this case, EFSA received from the Food Standards Agency, UK, an application for evaluation of
acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2-
hydroxypropylester, and acrylic acid, cross-linked to be used as liquid absorber in the form of fibres
in absorbent pads for the packaging of fresh or frozen meat, poultry, fish, fresh fruits and vegetables.
EFSA also received from Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, an
application for evaluation of the same substance as active component in two more commercial
products.
TERMS OF REFERENCE AS PROVIDED BY THE LEGISLATION

EFSA is required to carry out an assessment on the risks originating from the migration into food of
the substance acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid,
2-hydroxypropylester, and acrylic acid cross-linked, used as liquid absorber in food contact materials
and deliver a scientific opinion, according to the Regulation (EC) No 1935/2004 of the European
Parliament and of the Council on materials and articles intended to come into contact with food.
The absorber is used in absorbent pads together with cellulosic fluff pulp. Nevertheless this
evaluation will focus on acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester,
methacrylic acid, 2-hydroxypropylester, and acrylic acid cross-linked as materials and articles
functioning on the basis of the natural constituents only, such as pads composed of 100 % cellulose,
are not designed to deliberately incorporate components that would release or absorb substances
hence do not fall under the definition of active materials and articles of the Commission Regulation
(EC) No 450/2009 (European Commission, 2011).
The opinion of EFSA will be considered by the Commission for adoption of a Community list of
authorised substances where according to the Commission Regulation (EC) No 450/2009 there will be
specified:
(a) the identity of the substance(s);
(b) the function of the substance(s);
EFSA Journal 2013;11(4):3154 4

(c) the reference number;
(d) if necessary, the conditions of use of the substance(s) or component;
(e) if necessary, restrictions and/or specifications of use of the substance(s);
(f) if necessary, conditions of use of the material or article to which the substance or component is
added or into which it is incorporated.
EFSA Journal 2013;11(4):3154 5

ASSESSMENT
1. Introduction
The European Food Safety Authority was asked by the Food Standards Agency, UK, to evaluate the
safety of acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2-
hydroxypropylester, and acrylic acid, cross-linked, with CAS number 117675-55-5 and FCM
substance No 1022, used as a liquid absorber in absorbent pads. The request has been registered in the
EFSA’s register of questions under the number EFSA-Q-2011-00200. The dossier was submitted on
behalf of Technical Absorbents Ltd.
In addition EFSA was asked by the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit,
Germany to evaluate the safety of the same substance for the same function in two more commercial
products. The request has been registered in the EFSA’s register of questions under the number
EFSA-Q-2011-00222. The dossier was submitted by McAirlaid’s Vliesstoffe GmbH & Co KG. The
evaluation of this application is included into this opinion.
2. General information
According to applicants, acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester,
methacrylic acid, 2-hydroxypropylester, and acrylic acid, cross-linked is intended to be used typically
up to 33 % w/w in absorbent pads in packaging of fresh meat, poultry, and fish (incl. seafood) as well
as fruits and vegetables in order to absorb liquid released from the food at ambient, cool and frozen
conditions.
The polymer is applied in the form of fibres (length 6 mm and diameter 0.025 mm) in nonwoven
fabrics in which they are entangled during the manufacturing process with other fibrous material such
as cellulosic fluff-pulp what prevents mechanical transfer of the polymeric fibres into the food.
Manufacturing techniques (e.g. inclusion of thermally bondable fibres in the nonwoven fabric,
calendaring) which may be additionally used in the manufacture of the nonwoven fabrics contribute to
prevent mechanical transfer of the polymeric fibres into the food. The nonwoven fabric containing the
polymer can be used alone or covered, either on one or on both sides, with plastic film or other
nonwoven fabric not containing the polymer. Liquids are absorbed and retained in the absorbent core
by the formation of a hydrogel.
The polymer has not been evaluated by SCF or EFSA in the past. However:
Acrylic acid (CAS 79-10-7, FCM Substance No 147) and acrylic acid, sodium salt (as a salt of an
authorised acid) are authorised as monomers for plastic materials and articles in contact with food
(Commission Regulation (EU) No 10/2011) with a group SML of 6 mg/kg food, expressed as acrylic
acid.
Acrylic acid, methyl ester (CAS 96-33-3, FCM Substance No 176) is authorised as a monomer for
plastic materials and articles in contact with food (Commission Regulation (EU) No 10/2011) with a
group SML of 6 mg/kg food, expressed as acrylic acid.
Methacrylic acid, 2-hydroxypropyl ester EFSA has been evaluated by EFSA for use as monomer in
acrylic resin coatings for food cans (EFSA Scientific Panel on Food Contact Materials, Enzymes,
Flavourings and Processing Aids (CEF), 2012). The Panel considered that it does not raise concern
for genotoxicity.
EFSA Journal 2013;11(4):3154 6

3. Data available in the dossier used for this evaluation

The studies submitted for evaluation followed the EFSA guidelines on submission of a dossier for
safety evaluation by the EFSA of active or intelligent substances present in active and intelligent
materials and articles intended to come into contact with food (EFSA, 2009).
Non-toxicity data:
− Data on identity
− Data on physical and chemical properties
− Data on polymeric fibres
− Data on manufacturing process
− Data on function, intended use and authorisation
− Data on migration of residual amounts of starting substances
− Data on residual content
Toxicity data:
− Bacterial gene mutation test
4. Evaluation
4.1. Non-toxicological data

Structure: (-AA-)w (-AANa-)x (-MA-)y (-HPMA-)z
AA - acrylic acid w = 20 – 25 %
AANa - acrylic acid, sodium salt x = 52 – 62 %
MA - acrylic acid, methyl ester y = 15 – 20 %
HPMA - methacrylic acid, 2-hydroxypropylester z = 0.25 – 2 %
The cross-linked polymer in the form of fibres with a mean length of 6 mm and diameter 0.025 mm is
incorporated in nonwoven fabric during the manufacturing process. It is stable under the temperature
conditions of processing and use. It has a water soluble fraction of 28 %. This soluble fraction has a
weight average molecular weight of 126,000 – 138,000 Da and a number average molecular weight of
5470 – 7820 Da. In this soluble fraction, the oligomeric species with a molecular weight below 1000
Da is maximum 0.8 %. The residual content of methacrylic acid, 2-hydroxypropylester in the polymer
was determined by extraction with 95 % ethanol and iso-octane. It was not detectable at a detection
limit of 1 mg/kg polymer.
The absorbed fluid is retained in the cross-linked polymer by transformation into a gel. The capacity
of the polymer to absorb liquid was measured for a 0.9 % saline solution. It was found to be 50 g fluid
per g polymer.
Specific migration tests by total immersion into aqueous simulants were performed on a sample
containing 30 % of the cross-linked polymer. Although testing by total immersion is considered to be
unrepresentatively severe, migration results were very low at 0.2 mg/kg for acrylic acid and not
detectable (less than 0.18 mg/kg) for methacrylic acid and so well below the limits set in the
Commission Regulation (EU) No 10/2011. Moreover, the Panel considered that migration is not
EFSA Journal 2013;11(4):3154 7

expected when the absorber pads are used under realistic conditions in which the absorption capacity
is not exceeded. Therefore no exposure from the consumption of the packed food is expected.
4.2. Toxicological data

The monomers acrylic acid (CAS 79-10-7, FCM No 147) and acrylic acid, methyl ester (CAS 96-33-
3, FCM No 176), were evaluated by the Scientific Committee for Food (SCF, 1986 and 1993,
respectively) and are both listed in the Commission Regulation (EU) No 10/2011 with a group SML
of 6 mg/kg food.
According to data recently evaluated by EFSA on methacrylic acid, 2-hydroxypropyl ester (EFSA
Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), 2012),
the monomer does not raise concern for genotoxicity.
In addition, the polymer acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester,
methacrylic acid, 2-hydroxypropylester, and acrylic acid, cross-linked, does not induce gene
mutations in an adequately performed in vitro genotoxicity test (OECD TG 471) with and without
metabolic activation.
None of these starting substances give rise to concern for genotoxicity. Considering this, also the size
of the cross-linked polymer and its blocked functional groups and that it does not induce gene
mutations in an adequately performed in vitro genotoxicity test, the Panel concluded that the cross-
linked polymer does not raise concern for genotoxicity.
CONCLUSIONS
The CEF Panel, after having considered the above mentioned data, concluded that the use of the
substance acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2-
hydroxypropylester, and acrylic acid, cross-linked, does not raise a safety concern when used in
absorber pads for the packaging of fresh or frozen meat, poultry, fish, fresh fruits and vegetables
under conditions in which the absorption capacity of the pads is not exceeded and the mechanical
release of the fibers from the pads is excluded.
DOCUMENTATION PROVIDED TO EFSA

1. Oasis SAF® superabsorbent fibres. February 2011. Submitted by Intertek Expert Services
on behalf of the applicant Technical Absorbents Ltd.
2. McAirlaid’s Meatpads MP-X and Fruit-Pads FRP-s. February 2011. Submitted by

McAirlaid’s Vliesstoffe GmbH & Co KG.
REFERENCES
EC (European Commission), 2011. EU Guidance to the Commission Regulation (EC) No 450/2009 of

29 May 2009 on active and intelligent materials and articles intended to come into contact with
food. Version 1.0. Available from:
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/docs/guidance_active_and_intelligent_sc
ofcah_231111_en.pdf
EFSA (European Food Safety Authority), 2009. Guidelines on submission of a dossier for safety
evaluation by the EFSA of active or intelligent substances present in active and intelligent
EFSA Journal 2013;11(4):3154 8

materials and articles intended to come into contact with food. The EFSA Journal 2009, 1208, 1-
11. Available from: http://www.efsa.europa.eu/en/efsajournal/doc/1208.pdf
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), 2012.
Scientific Opinion on the safety evaluation of the substance, methacrylic acid, 2-hydroxypropyl
ester, CAS No 27813-02-1, for use in food contact materials. EFSA Journal 2012, 10(6):2745, 9
pp. doi:10.2903/j.efsa.2012.2745
SCF (Scientific Committee for Food), 1986. Reports of the Scientific Committee for Food (17th
Series). Report of the Scientific Committee for Food on certain monomers and other starting
substances to be used in the manufacturing of plastic materials intended to come into contact with
foodstuffs. http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_17.pdf.
SCF (Scientific Committee for Food), 1993. Reports of the Scientific Committee for Food (30th
Series). Third addendum to the first report of the Scientific Committee for Food on certain
monomers and other starting substances to be used in the manufacturing of plastic materials
intended to come into contact with foodstuffs.
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_30.pdf.
EFSA Journal 2013;11(4):3154 9

GLOSSARY AND ABBREVIATIONS

CAS Chemical Abstracts Service
CEF Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing
Aids
EC European Commission
EFSA European Food Safety Authority
EU European Union
FCM Food Contact Materials
OECD Organisation for Economic Co-operation and Development
OECD TG OECD Test Guidelines
SCF Scientific Committee on Food
SML Specific Migration Limit
EFSA Journal 2013;11(4):3154 10

EFSA Journal - 2013 - Scientific Opinion On The Safety Evaluation of The Active Substance Acrylic Acid Sodium Salt

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EFSA Journal 2013;11(4):3154

Scientific Opinion on the safety evaluation of the active substance,

European Food Safety Authority (EFSA), Parma, Italy

© European Food Safety Authority, 2013

© European Food Safety Authority, 2013

EFSA Journal 2013;11(4):3154 2

EFSA Journal 2013;11(4):3154 3

BACKGROUND AS PROVIDED BY THE LEGISLATION

TERMS OF REFERENCE AS PROVIDED BY THE LEGISLATION

(a) the identity of the substance(s);

(b) the function of the substance(s);

EFSA Journal 2013;11(4):3154 4

(c) the reference number;

(d) if necessary, the conditions of use of the substance(s) or component;

(e) if necessary, restrictions and/or specifications of use of the substance(s);

EFSA Journal 2013;11(4):3154 5

EFSA Journal 2013;11(4):3154 6

3. Data available in the dossier used for this evaluation

− Bacterial gene mutation test

4.1. Non-toxicological data

AANa - acrylic acid, sodium salt x = 52 – 62 %

MA - acrylic acid, methyl ester y = 15 – 20 %

HPMA - methacrylic acid, 2-hydroxypropylester z = 0.25 – 2 %

EFSA Journal 2013;11(4):3154 7

4.2. Toxicological data

DOCUMENTATION PROVIDED TO EFSA

2. McAirlaid’s Meatpads MP-X and Fruit-Pads FRP-s. February 2011. Submitted by

EC (European Commission), 2011. EU Guidance to the Commission Regulation (EC) No 450/2009 of

EFSA Journal 2013;11(4):3154 8

EFSA Journal 2013;11(4):3154 9

GLOSSARY AND ABBREVIATIONS

EFSA Journal 2013;11(4):3154 10

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