See Full Document Text
Official Journal EN
of the European Union L series
2026/196 29.1.2026
COMMISSION REGULATION(EU) 2026/196
of 28 January 2026
amending Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards
the use of carrageenan (E 407), locust bean gum (E 410), guar gum (E 412), gum arabic (acacia gum)
(E 414), xanthan gum (E 415), pectins (E 440) and starch sodium octenyl succinate (E 1450) and
Commission Regulation (EU) No 231/2012 as regards specifications for locust bean gum (E 410), guar
gum (E 412), gum arabic (acacia gum) (E 414), xanthan gum (E 415), pectins (E 440) and starch sodium
octenyl succinate (E 1450)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on
food additives(1), and in particular Article 10(3) and Article 14 thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008
establishing a common authorisation procedure for food additives, food enzymes and food flavourings(2), and in
particular Article 7(5) thereof,
Whereas:
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and
their conditions of use.
(2) Commission Regulation (EU) No 231/2012(3)lays down specifications for food additives that are listed in Annexes II
and III to Regulation (EC) No 1333/2008.
(3) The Union list of food additives may be updated in accordance with the common procedure referred to in Article 3(1)
of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.
(4) Locust bean gum (E 410), guar gum (E 412), gum arabic (acacia gum) (E 414), xanthan gum (E 415), pectins (E 440)
and starch sodium octenyl succinate (E 1450) are food additives authorised in accordance with Regulation (EC)
No 1333/2008.
(5) On 20 January 2017, the European Food Safety Authority (‘the Authority’) issued a scientific opinion on the
re-evaluation of locust bean gum (E 410) as a food additive(4). The Authority concluded that there was no need for a
numerical acceptable daily intake (‘ADI’) and that there would be no safety concern at the reported uses and use
levels. However, infants and young children consuming foods for special medical purposes may show a higher
susceptibility to the gastrointestinal effects of locust bean gum (E 410) due to their underlying medical condition.
The Authority concluded that the available data did not allow an adequate assessment of the safety of locust bean
gum (E 410) when used in foods for special medical purposes intended for infants and for young children (food
categories 13.1.5.1 and 13.1.5.2). The Authority recommended some modifications to the specifications for locust
bean gum (E 410) set out in Regulation (EU) No 231/2012. In addition, the Authority recommended including
carrageenan (E 407) in Annex II to Regulation (EC) No 1333/2008 in the footnote for ‘milk-based drinks and similar
products intended for young children’ (current food category 01.10) regulating the combined use of the gums.
(1) OJ L 354, 31.12.2008, p. 16, ELI: http://data.europa.eu/eli/reg/2008/1333/oj.
(2) OJ L 354, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1331/oj.
(3) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III
to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1, ELI: http://data.europa.
eu/eli/reg/2012/231/oj).
(4) EFSA Journal2017;15(1):4646 (https://doi.org/10.2903/j.efsa.2017.4646).
ELI: http://data.europa.eu/eli/reg/2026/196/oj 1/18EN
OJ L, 29.1.2026
(6) On 18 July 2018, the Authority launched a public call for technical and toxicological data on locust bean gum
(E 410) for uses in foods for all population groups including infants below 16 weeks of age, to collect the data
needed for addressing its recommendations for that food additive. Business operators provided data in response to
the call.
(7) On 9 February 2023, the Authority issued a ‘scientific opinion on the re-evaluation of locust bean gum (E 410) as a
food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses
in foods for all population groups’(5). The Authority concluded that that the use of locust bean gum (E 410) in foods
falling under food categories 13.1.5.1 and 13.1.5.2 raises safety risks.As regards the specification as laid down in
Regulation (EU) No 231/2012, the Authority recommended amending the definition, reducing the maximum limits
for toxic elements (lead, arsenic, mercury and cadmium), changing the word ‘soluble’ to ‘fully dispersible’ based on
the consideration that hydrocolloids form colloidal dispersions in water instead of true solutions, and including
microbiological criteria.
(8) It is therefore appropriate to revise the conditions of use of locust bean gum (E 410) in food categories 13.1.5.1
and 13.1.5.2 and amend its definition and specifications in light of the Authority’s scientific opinion. In particular,
in its specifications, the current maximum limits for toxic elements should be reduced and microbiological criteria
should be laid down in accordance with the scientific opinion of the Authority and taking into account the level
which is currently achievable by the application of good manufacturing practices. Furthermore, the word ‘soluble’
should be changed to ‘fully dispersible’.
(9) On 24 February 2017, the Authority issued a scientific opinion on the re-evaluation of guar gum (E 412) as a food
additive(6). The Authority concluded that there was no need for a numerical ADI and that there would be no safety
concern at the reported uses and use levels. The Authority also concluded that the available data did not allow an
adequate assessment of the safety of guar gum (E 412) when used in foods for special medical purposes intended for
infants and for young children (food categories 13.1.5.1 and 13.1.5.2). The Authority recommended some
modifications to the specifications for guar gum (E 412) set out in Regulation (EU) No 231/2012.
(10) On 18 July 2018, the Authority launched a public call for technical and toxicological data on guar gum (E 412) for
uses in foods for all population groups including infants below 16 weeks of age, to collect the data needed for
addressing its recommendations for that food additive. Business operators provided data in response to the call.
(11) On 21 March 2024, the Authority issued a ‘scientific opinion on the re-evaluation of guar gum (E 412) as a food
additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in
foods for all population groups’(7). As regards its specifications as laid down in Regulation (EU) No 231/2012, the
Authority recommended reducing the maximum limits for toxic elements, changing the words ‘solution/soluble’ to
‘dispersion/dispersible’, including microbiological criteria and specifying the Kjeldahl method for protein analysis.
The Authority concluded that the submitted data are not sufficient to demonstrate the safety of the use of guar gum
(E 412) in infant formula and foods for special medical purposes falling under food categories 13.1.1, 13.1.5.1 or
13.1.5.2.
(12) It is therefore appropriate to withdraw the authorisation of guar gum (E 412) in food categories 13.1.1, 13.1.5.1
and 13.1.5.2 and amend its specifications in light of the Authority’s scientific opinion. In particular, the definition
should contain the way of processing. In the specifications, the current maximum limits for toxic elements should be
reduced and microbiological criteria should be laid down in accordance with the scientific opinion of the Authority
and taking into account the level which is currently achievable by the application of good manufacturing practices.
Given the withdrawal of the authorisation of guar gum (E 412) in food categories 13.1.1, 13.1.5.1 and 13.1.5.2 it is
not necessary to establish a criterion for Cronobacter spp. (Enterobacter sakazakii), which is particularly relevant for
foods intended for infants below 6 months of age. Furthermore, the Kjeldahl method should be specified for protein
analysis and the words ‘solution/soluble’ should be changed to ‘dispersion/dispersible’.
(5) EFSA Journal2023;21(2):7775 (https://doi.org/10.2903/j.efsa.2023.7775).
(6) EFSA Journal2017;15(2):4669 (https://doi.org/10.2903/j.efsa.2017.4669).
(7) EFSA Journal2024;22:e8748 (https://doi.org/10.2903/j.efsa.2024.8748).
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(13) On 6 April 2017, the Authority issued a scientific opinion on the re-evaluation of gum arabic (acacia gum) (E 414) as
a food additive(8). The Authority concluded that there was no need for a numerical ADI and that there would be no
safety concern at the reported uses and use levels. The Authority recommended some modifications to the
specifications for gum arabic (acacia gum) (E 414) set out in Regulation (EU) No 231/2012.
(14) On 10 October 2018, the Authority launched a public call for technical and toxicological data on gum arabic (acacia
gum) (E 414) for uses in foods for all population groups including infants below 16 weeks of age, to collect the data
needed for addressing its recommendations for that food additive. Business operators provided data in response to
the call.
(15) On 13 December 2019, the Authority issued a ‘scientific opinion on the re-evaluation of gum arabic (acacia gum)
(E 414) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food
additive for uses in foods for all population groups’(9). The Authority concluded that the use of gum arabic (acacia
gum) (E 414) at the current use levels does not raise health risks. As regards its specifications as laid down in
Regulation (EU) No 231/2012, the Authority recommended reducing the maximum limits for toxic elements,
including a maximum limit for aluminium and proteins, amending the microbiological criteria, and specifying that
oxidases and peroxidases are inactivated.
(16) It is therefore appropriate to amend the specifications of gum arabic (acacia gum) (E 414) in light of the Authority’s
scientific opinion. In particular, maximum limits for aluminium and proteins should be laid down, the current
maximum limits for toxic elements as well as the microbiological criteria should be amended, in accordance with
the scientific opinion of the Authority and considering the level which is currently achievable by the application of
good manufacturing practices. Furthermore, it should be specified that oxidases and peroxidases should be
inactivated during the manufacturing process when used in foods for infants and young children. Considering that
gum arabic (acacia gum) (E 414) is a hydrocolloid that forms colloidal dispersions in water instead of true solutions,
the recommendation by the Authority to change the words ‘solution/soluble’ to ‘dispersion/dispersible’ made for
other hydrocolloids should also be applied as regards gum arabic (acacia gum) (E 414).
(17) On 14 July 2017, the Authority issued a scientific opinion on the re-evaluation of xanthan gum (E 415) as a food
additive(10). The Authority concluded that there was no need for a numerical ADI and that there would be no safety
concern at the reported uses and use levels. The Authority specified that re-evaluation of xanthan gum (E 415) as a
food additive did not cover infants below 12 weeks of age. The Authority recommended some modifications to the
specifications for xanthan gum (E 415) set out in Regulation (EU) No 231/2012.
(18) On 18 July 2018, the Authority launched a public call for technical and toxicological data on xanthan gum (E 415)
for uses in foods for all population groups including infants below 16 weeks of age, to collect the data needed for
addressing its recommendations for that food additive. Business operators provided data in response to the call.
(19) On 21 March 2023, the Authority issued a ‘scientific opinion on the re-evaluation of xanthan gum (E 415) as a food
additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in
foods for all population groups’(11). The Authority concluded that there are no safety concerns for infants below 16
weeks of age resulting from the use of xanthan gum (E 415) as a food additive in food category 13.1.5.1. As regards
its specifications as laid down in Regulation (EU) No 231/2012, the Authority recommended to modify the
definition of xanthan gum (E 415), reducing the maximum limit for lead and considering the adoption of maximum
limits for arsenic, mercury and cadmium. The Authority also recommended changing the words ‘solution/soluble’ to
‘dispersion/dispersible’, amending the microbiological criteria and specifying the Kjeldahl method for nitrogen
analysis. It is therefore appropriate to amend the specifications of xanthan gum (E 415) accordingly. In light of the
Authority’s scientific opinion, it is therefore appropriate to amend the definition and the specifications of xanthan
gum (E 415).
(8) EFSA Journal2017;15(4):4741 (https://doi.org/10.2903/j.efsa.2017.4741).
(9) EFSA Journal2019;17(12):5922 (https://doi.org/10.2903/j.efsa.2019.5922).
(10) EFSA Journal2017;15(7):4909 (https://doi.org/10.2903/j.efsa.2017.4909).
(11) EFSA Journal2023;21(5):7951 (https://doi.org/10.2903/j.efsa.2023.7951).
ELI: http://data.europa.eu/eli/reg/2026/196/oj 3/18EN
OJ L, 29.1.2026
(20) On 6 July 2017, the Authority issued a scientific opinion on the re-evaluation of pectin (E 440i) and amidated pectin
(E 440ii) as food additives(12). The Authority concluded that there was no need for a numerical ADI and that there
would be no safety concern at the reported uses and use levels. It considered that the available data did not allow for
an adequate assessment of the safety of pectins (E 440) in infants and young children consuming foods belonging to
food categories 13.1.5.1 and 13.1.5.2. The Authority recommended some modifications to the definition and
specifications of pectin (E 440i) and amidated pectin (E 440ii) set out in Regulation (EU) No 231/2012.
(21) On 18 July 2018, the Authority launched a public call for technical and toxicological data on pectin (E440i) and
amidated pectin (E 440ii) for uses as food additives in foods for all population groups including infants below 16
weeks of age, to collect the data needed for addressing its recommendations for those food additives and to carry out
the assessment of the safety of pectins (E 440) for infants and young children consuming foods belonging to food
categories 13.1.5.1 and 13.1.5.2. Business operators provided data in response to the call.
(22) On 29 January 2021, the Authority issued a ‘scientific opinion on the re-evaluation of pectin (E 440i) and amidated
pectin (E 440ii) as food additives in foods for infants below 16 weeks of age and follow-up of their re-evaluation as
food additives for uses in foods for all population groups’(13). The Authority concluded that the use of pectins
(E 440) in food categories 13.1.5.1 and 13.1.5.2 at the currently authorised levels raise health risks. As regards their
specifications as laid down in Regulation (EU) No 231/2012, the Authority recommended reducing the maximum
limits for toxic elements, including a maximum limit for aluminium and including microbiological criteria.
(23) It is therefore appropriate to revise the conditions of use of pectins (E 440) in food categories 13.1.5.1 and 13.1.5.2
and amend their definition and specifications in light of the Authority’s scientific opinion. In particular, in their
specifications, the current maximum limits for toxic elements should be reduced, a maximum limit for aluminium
should be laid down, and microbiological criteria should be laid down in accordance with the scientific opinion of
the Authority and considering the level which is currently achievable by the application of good manufacturing
practices. Considering that pectins (E 440) are hydrocolloids that form colloidal dispersions in water instead of true
solutions, the recommendation by the Authority to change the words ‘solution/soluble’ to ‘dispersion/dispersible’
made for other hydrocolloids is also applicable to pectins (E 440).
(24) On 5 October 2017, the Authority issued a scientific opinion on the re-evaluation of oxidised starch (E 1404),
monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated
distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch
(E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised
starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives(14). The Authority concluded that
there was no need for a numerical ADI and that there would be no safety concern at the reported uses and use levels.
It was specified that the available data did not allow for an adequate assessment of the safety of starch sodium octenyl
succinate (E 1450) in infants and young children consuming foods belonging to food categories 13.1.5.1
and 13.1.5.2. The Authority recommended some modifications to the definition and specifications of starch sodium
octenyl succinate (E 1450) set out in Regulation (EU) No 231/2012.
(25) On 18 July 2018, the Authority launched a public call for technical and toxicological data on starch sodium octenyl
succinate (E 1450) for uses as a food additive in foods for all population groups including infants below 16 weeks of
age, to collect the data needed to carry out the assessment of its safety for infants and young children consuming
foods belonging to food categories 13.1.5.1 and 13.1.5.2. Business operators provided data in response to the call.
(12) EFSA Journal2017;15(7):4866 (https://doi.org/10.2903/j.efsa.2017.4866).
(13) EFSA Journal2021;19(1):6387 (https://doi.org/10.2903/j.efsa.2021.6387).
(14) EFSA Journal2017;15(10):4911 (https://doi.org/10.2903/j.efsa.2017.4911).
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(26) On 13 August 2020, the Authority issued a ‘scientific opinion on the re-evaluation of starch sodium octenyl
succinate (E 1450) as a food additive in foods for infants below 16 weeks of age and the follow-up of its
re-evaluation as a food additive for uses in foods for all population groups’(15). As regards its specifications as laid
down in Regulation (EU) No 231/2012, the Authority recommended reducing the maximum limits for sulphur
dioxide, arsenic, lead and mercury, including a maximum limit for cadmium, specifying that starch sodium octenyl
succinate (E 1450) is not to contain gluten when used in infant formula and follow-on formula and including
microbiological criteria. The Authority concluded that there is no indication for safety concern when the dietary
exposure of infants and young children consuming foods belonging to food categories 13.1.5.1 and 13.1.5.2 is
within the dose range reported in the clinical studies (up to 2 725 mg/kg bw per day). However, the Authority noted
that at the reported use levels, the estimates of exposure could exceed this dose.
(27) It is therefore appropriate to revise the conditions of use of starch sodium octenyl succinate (E 1450) in food
categories 13.1.5.1 and 13.1.5.2 and amend its specifications in light of the Authority’s scientific opinion. In
particular, in its specifications, the current maximum limits for sulphur dioxide, arsenic, lead and mercury should be
reduced, a maximum limit for cadmium as well as microbiological criteria should be laid down in accordance with
the scientific opinion of the Authority and considering the level which is currently achievable by the application of
good manufacturing practices. Furthermore, it should be specified that starch sodium octenyl succinate (E 1450)
used in infant formula and follow-on formula should not contain gluten. Considering that starch sodium octenyl
succinate (E 1450) is a hydrocolloid that forms colloidal dispersions in water instead of true solutions, the
recommendation by the Authority to change the words ‘solution/soluble’ to ‘dispersion/dispersible’ made for other
hydrocolloids is also applicable to starch sodium octenyl succinate (E 1450).
(28) Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.
(29) Considering that the Authority did not identify an immediate health concern linked to the current specifications for
locust bean gum (E 410), guar gum (E 412), gum arabic (acacia gum) (E 414), xanthan gum (E 415), pectins (E 440)
and starch sodium octenyl succinate (E 1450) and in order to allow the food business operators, including small and
medium enterprises, to adapt to the new more stringent specifications laid down in this Regulation, the application of
the new specifications should be deferred and a transitional period should be provided for the use of those food
additives lawfully placed on the market before the date of application of this Regulation.
(30) For the same reasons, a transitional period should be provided for foods containing locust bean gum (E 410), guar
gum (E 412), gum arabic (acacia gum) (E 414), xanthan gum (E 415), pectins (E 440) or starch sodium octenyl
succinate (E 1450) that have been lawfully placed on the market before the date of application of this Regulation.
(31) Considering that the Authority did not identify an immediate health concern linked to the conditions of use of certain
food additives which are amended by this Regulation and in order to allow the food business operators, including
small and medium enterprises, to adapt to the new conditions of use laid down in this Regulation, the application of
those conditions should be deferred by six months and a transitional period should be provided for food lawfully
placed on the market before the date of application of this Regulation. However, considering the different steps
needed for the reformulation of foods belonging to food categories 13.1.5.1 and 13.1.5.2 to adapt to the new
conditions of use of starch sodium octenyl succinate (E 1450), in order to ensure the availability of foods belonging
to these food categories, the application of the new conditions of use for that food additive should be deferred for a
longer period.
(15) EFSA Journal2020;18(8):5874 (https://doi.org/10.2903/j.efsa.2020.5874).
ELI: http://data.europa.eu/eli/reg/2026/196/oj 5/18EN
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(32) Considering that the Authority did not identify an immediate health concern linked to the use of guar gum (E 412) in
food categories 13.1.1, 13.1.5.1 and 13.1.5.2 and in order to allow the food business operators, including small and
medium enterprises, to find alternative, the withdrawal of the authorisation concerning that use should be deferred
by six months and a transitional period should be provided for products placed on the market before the withdrawal
of the authorisation. However, since guar gum (E 412) in foods belonging to food category 13.1.5.2 is used in
combination with sodium carboxy methyl cellulose, cellulose gum (E 466) for which the authorisation was
withdrawn by Commission Regulation (EU) 2025/666(16)as of 27 April 2027, it is appropriate that the withdrawal
of the authorisation of use for guar gum (E 412) for that food category is deferred until that date.
(33) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Article 2
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Article 3
1. The food additives locust bean gum (E 410), guar gum (E 412), gum arabic (acacia gum) (E 414), xanthan gum
(E 415), pectins (E 440) and starch sodium octenyl succinate (E 1450) that have been lawfully placed on the market before
18 August 2026 may be added to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 until the
exhaustion of stocks.
2. Foods, to which locust bean gum (E 410), guar gum (E 412), gum arabic (acacia gum) (E 414), xanthan gum (E 415),
pectins (E 440) or starch sodium octenyl succinate (E 1450) that have been lawfully placed on the market before 18 August
2026 are added, may be placed on the market until their date of minimum durability or ‘use-by date’.
3. Foods, not complying with provisions laid down in Annex I, that have been lawfully placed on the market before
18 August 2026 or, in the case of foods containing starch sodium octenyl succinate (E 1450) before 18 February 2028,
may continue to be marketed until their date of minimum durability or ‘use-by’ date.
4. Foods, that have been lawfully placed on the market before 18 August 2026 belonging to food categories 13.1.1
‘Infant formulae as defined by Regulation (EU) No 609/2013’ and 13.1.5.1 ‘Foods for special medical purposes, as defined
by Regulation (EU) No 609/2013, intended for infants’ and containing guar gum (E 412) may continue to be marketed
until their date of minimum durability or ‘use-by date’.
(16) Commission Regulation (EU) 2025/666 of 4 April 2025 amending Annex II and Annex III to Regulation (EC) No 1333/2008 of the
European Parliament and of the Council as regards the use of sodium carboxy methyl cellulose, cellulose gum (E 466) and the Annex
to Commission Regulation (EU) No 231/2012 as regards specifications for cellulose (E 460), methyl cellulose (E 461), ethyl cellulose
(E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy
methyl cellulose, cellulose gum (E 466), cross-linked sodium carboxy methyl cellulose, cross linked cellulose gum (E 468) and
enzymatically hydrolysed carboxy methyl cellulose (E 469) (OJ L, 2025/666, 7.4.2025, ELI: http://data.europa.eu/eli/reg/2025/666/oj).
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5. Foods, that have been lawfully placed on the market before 27 April 2027 belonging to food category 13.1.5.2
‘Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants as from four months
of age and for young children’ and containing guar gum (E 412) may continue to be marketed until their date of minimum
durability or ‘use-by date’.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
It shall apply from 18 August 2026.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 January 2026.
For the Commission
The President
Ursula VON DER LEYEN
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OJ L, 29.1.2026
ANNEX I
Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) in category 01.10 (‘Milk-based drinks and similar products intended for young children’):
(a) the entry for E 407 Carrageenan is replaced by the following:
‘E 407 Carrageenan 300 (X)’
(b) the entry for E 410 Locust bean gum is replaced by the following:
‘E 410 Locust bean gum 10 000 (X)’
(c) the entry for E 412 Guar gum is replaced by the following:
‘E 412 Guar gum 10 000 (X)’
(d) the entry for E 414 Gum arabic (acacia gum) is replaced by the following:
‘E 414 Gum arabic (acacia gum) 10 000 (X)’
(e) the entry for E 415 Xanthan gum is replaced by the following:
‘E 415 Xanthan gum 10 000 (X)’
(f) the entry for E 440 Pectins is replaced by the following:
‘E 440 Pectins 5 000 (X)’
(g) footnote (21) is deleted;
(h) the new footnote (X) is inserted after footnote (44):
‘(X): If more than one of the substances E 407, E 410, E 412, E 414, E 415 and E 440 is added to a
foodstuff, the maximum level established for that foodstuff for each of those substances is lowered
with that relative part as is present of the other substances together in that foodstuff’;
(2) in category 13.1.1 (‘Infant formulae as defined by Regulation (EU) No 609/2013’) the entry for E 412 Guar gum is
deleted;
(3) in category 13.1.5.1 (‘Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for
infants’):
(a) the first sentence is replaced by the following:
‘The additives of categories 13.1.1 and 13.1.2 are applicable, except for E 412.’;
(b) the entry for E 410 Locust bean gum is replaced by the following:
‘E 410 Locust bean gum 5 300 From birth onwards in products for
reduction of gastro-oesophageal reflux’
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(c) the entry for E 412 Guar gum is deleted;
(d) the entry for E 440 Pectins is replaced by the following:
‘E 440 Pectins 4 000 From birth onwards in products used
in case of gastro-intestinal disorders’
(e) the entry for E 1450 Starch sodium octenyl succinate is replaced by the following:
‘E 1450 Starch sodium octenyl 20 000 only in infant formulae and follow-on
succinate formulae
Period of application: until 18 February
2028
E 1450 Starch sodium octenyl 10 000 only in infant formulae and follow-on
succinate formulae
Period of application: from 18 February
2028’
(4) in category 13.1.5.2 (‘Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for
infants as from four months of age and for young children’):
(a) the first sentence is replaced by the following:
‘The additives of categories 13.1.2 and 13.1.3 are applicable, except for E 270, E 333, E 341, E 412.’;
(b) the entry for E 410 Locust bean gum is replaced by the following:
‘E 410 Locust bean gum 5 300 From birth onwards in products for
reduction of gastro-oesophageal reflux’
(c) the entry for E 412 Guar gum is replaced by the following;
‘E 412 Guar gum 10 000 From birth onwards in products in
liquid formulae containing hydrolysed
proteins, peptides or amino acids
Period of application:
until 27 April 2027’
(d) the entry for E 440 Pectins is replaced by the following:
‘E 440 Pectins 4 000 From birth onwards in products used
in case of gastro-intestinal disorders’
(e) the entry for E 1450 Starch sodium octenyl succinate is replaced by the following:
‘E 1450 Starch sodium octenyl 20 000 Period of application: until 18 February
succinate 2028
E 1450 Starch sodium octenyl 10 000 Period of application: from 18 February
succinate 2028’
ELI: http://data.europa.eu/eli/reg/2026/196/oj 9/18EN
OJ L, 29.1.2026
ANNEX II
The Annex to Regulation (EU) No 231/2012 is amended as follows:
(1) the entry for ‘E 410 LOCUST BEAN GUM’ is replaced by the following:
‘E 410 LOCUST BEAN GUM
Synonyms Carob bean gum; Algaroba gum
Definition Locust bean gum is the ground endosperm of the seeds of the strainsof carob
tree, Cerationia siliqua(L.) Taub. (family Leguminosae). The seeds are dehusked by
treating the kernels with dilute sulfuric acid or with thermal mechanical
treatments, elimination of the germ, followed by milling and screening of the
endosperm to obtain native locust bean gum. Locust bean gum consists mainly
of a high molecular weight hydrocolloidal polysaccharide, composed of
galactopyranose and mannopyranose units combined through glycosidic
linkages, which may be described chemically as galactomannan.
Einecs 232-541-5
CAS number 9000-40-2
Chemical name
Chemical formula
Molecular weight 50 000–3 000 000
Assay Galactomannan content not less than 75 %
Description White to yellowish-white, nearly odourless powder
Identification
Test for galactose Passes test
Test for mannose Passes test
Microscopic examination Place some ground sample in an aqueous solution containing 0,5 % iodine
and 1 % potassium iodide on a glass slide and examine under microscope.
Locust bean gum contains long stretched tubiform cells, separated or slightly
interspaced. Their brown contents are much less regularly formed than in guar
gum. Guar gum shows close groups of round to pear-shaped cells. Their
contents are yellow to brown
Solubility Fully dispersible in hot water, insoluble in ethanol
Purity
Loss on drying Not more than 15 % (105 °C, 5 hours)
Ash Not more than 1,2 % determined at 800 °C
Protein (N × 6,25) Not more than 7 %
Acid-insoluble matter Not more than 4 %
Starch Not detectable by the following method: to a 1 in 10 dispersion of the sample
add a few drops of iodine solution. No blue colour is produced.
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,4 mg/kg
Mercury Not more than 0,1 mg/kg
Cadmium Not more than 0,1 mg/kg
Ethanol and propan-2-ol Not more than 1 %, single or in combination
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Microbiological criteria
Total plate count Not more than 5 000 cfu/g
Yeast and moulds Not more than 500 cfu/g
Enterobacteriaceae Absent in 10 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Escherichia coli Absent in 1 g
Salmonellaspp. Absent in 25 g
Cronobacterspp. (Enterobacter Absent in 10 g (only if added to dried infant formulae and dried foods for
sakazakii) special medical purposes intended for infants below 6 months of age)‘
(2) the entry for ‘E 412 GUAR GUM’ is replaced by the following:
‘E 412 GUAR GUM
Synonyms Gum cyamopsis; Guar flour
Definition Guar gum is the ground endosperm of the seeds of strains of the guar plant,
Cyamopsis tetragonolobus(L.) Taub. (family Leguminosae). The germ and
endosperm are separated via milling and sieving. The hull is removed via
treatment with moist or dry, hot air and sieving. Consists mainly of a high
molecular weight hydrocolloidal polysaccharide composed of galactopyranose
and mannopyranose units combined through glycosidic linkages, which may be
described chemically as galactomannan. The gum may be partially hydrolysed
by either heat treatment, mild acid or alcaline oxidative treatment for viscosity
adjustment.
Einecs 232-536-0
CAS number 9000-30-0
Chemical name
Chemical formula
Molecular weight 50 000–8 000 000
Assay Galactomannan content not less than 75 %
Description A white to yellowish-white, nearly odourless powder
Identification
Test for galactose Passes test
Test for mannose Passes test
Solubility Dispersible in cold water
Purity
Loss on drying Not more than 15 % (105 °C, 5 hours)
Ash Not more than 5,5 % determined at 800 °C
Acid-insoluble matter Not more than 7 %
Protein Not more than 10 % (factor N × 6,25) (Kjeldahl method)
Starch Not detectable by the following method: to a 1 in 10 dispersion of the sample
add a few drops of iodine solution. No blue colour is produced.
Organic peroxides Not more than 0,7 meq active oxygen/kg sample
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OJ L, 29.1.2026
Furfural Not more than 1 mg/kg
Pentachlorophenol Not more than 0,01 mg/kg
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,2 mg/kg
Mercury Not more than 0,1 mg/kg
Cadmium Not more than 0,1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 cfu/g
Yeast and moulds Not more than 500 cfu/g
Enterobacteriaceae Absent in 10 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Escherichia coli Absent in 1 g
Salmonellaspp. Absent in 25 g’
(3) the entry for ‘E 414 ACACIA GUM’ is replaced by the following:
‘E 414 GUM ARABIC (ACACIA GUM)
Synonyms
Definition Acacia gum is a dried exudation obtained from the stems and branches of
strains of Acacia senegal(L) Willdenow or closely related species of Acacia
(family Leguminosae). It consists mainly of high molecular weight
polysaccharides and their calcium, magnesium and potassium salts, which on
hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid.
Einecs 232-519-5
CAS number 9000-01-5
Chemical name
Chemical formula
Molecular weight Approximately 350 000
Assay
Description Unground acacia gum occurs as white or yellowish-white spheroidal tears of
varying sizes or as angular fragments and is sometimes mixed with darker
fragments. It is also available in the form of white to yellowish-white flakes,
granules, powder or spray-dried material.
Identification
Solubility 1 g dissolves in 2 ml of cold water forming a dispersion which flows readily and
is acid to litmus, insoluble in ethanol.
Purity
Loss on drying Not more than 17 % (105 °C, 5 hours) for granular and not more than 10 %
(105 °C, 4 hours) for spray-dried material
Total ash Not more than 4 %
Acid insoluble ash Not more than 0,5 %
Acid insoluble matter Not more than 1 %
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OJ L, 29.1.2026
Starch or dextrin Boil a 1 in 50 dispersion of the gum and cool. To 5 ml add 1 drop of iodine
solution. No bluish or reddish colours are produced.
Tannin To 10 ml of a 1 in 50 dispersion add about 0,1 ml of ferric chloride solution
(9 g FeCl .6H O made up to 100 ml with water). No blackish colouration or
3 2
blackish precipitate is formed.
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,05 mg/kg
Mercury Not more than 0,05 mg/kg
Cadmium Not more than 0,05 mg/kg
Aluminium Not more than 100 mg/kg (only if added to foods for infants and young
children)
Not more than 200 mg/kg (for all uses except for foods intended for infants and
young children)
Hydrolysis products Mannose, xylose and galacturonic acid are absent (determined by
chromatography).
Proteins Not more than 3,5 %
Oxidases and peroxidases occurring in acacia gum naturally or as a result of
processing should be inactivated during the manufacturing process of acacia
gum used in foods for infants and young children.
Microbiological criteria
Total plate count Not more than 10 000 cfu/g
Yeast and moulds Not more than 10 000 cfu/g
Salmonellaspp. Absent in 25 g
Enterobacteriaceae Absent in 10 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Escherichia coli Absent in 5 g
Cronobacterspp. (Enterobacter Absent in 10 g (only if added to dried infant formulae and dried foods for
sakazakii) special medical purposes intended for infants below 6 months of age)’
(4) the entry for ‘E 415 XANTHAN GUM’ is replaced by the following:
‘E 415 XANTHAN GUM
Synonyms
Definition Xanthan gum is a high molecular weight polysaccharide gum produced by a
pure-culture fermentation of a carbohydrate with strains of Xanthomonas
campestris, which are unequivocally identified and meet the criteria for
qualification for QPS status (i.e. absence of acquired antimicrobial resistance
genes), purified by recovery with ethanol or propan-2-ol, dried and milled. It
contains D-glucose and D-mannose as the dominant hexose units, along with
D-glucuronic acid, pyruvic acid and acetic acid, and is prepared as the sodium,
potassium or calcium salt. Its dispersions in water are neutral. The final product
must not show any residual enzyme activity.
Einecs 234-394-2
CAS number 11138-66-2
ELI: http://data.europa.eu/eli/reg/2026/196/oj 13/18EN
OJ L, 29.1.2026
Chemical name
Chemical formula
Molecular weight Approximately 1 000 000
Assay Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO
2
corresponding to between 91 % and 108 % of xanthan gum
Description Cream-coloured powder
Identification
Solubility Dispersible in water. Insoluble in ethanol.
Purity
Loss on drying Not more than 15 % (105 °C, 2,5 hours)
Total ash Not more than 16 % on the anhydrous basis determined at 650 °C after drying
at 105 °C for four hours
Pyruvic acid Not less than 1,5 %
Nitrogen Not more than 1,5 % (Kjeldahl method)
Ethanol and propan-2-ol Not more than 500 mg/kg singly or in combination
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,5 mg/kg
Mercury Not more than 0,05 mg/kg
Cadmium Not more than 0,3 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 cfu/g
Yeast and moulds Not more than 300 cfu/g
Enterobacteriaceae Absent in 10 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Escherichia coli Absent in 5 g
Salmonellaspp. Absent in 25 g
Cronobacterspp. (Enterobacter Absent in 10 g (only if added to dried infant formulae and dried foods for
sakazakii) special medical purposes intended for infants below 6 months of age)
Xanthomonas campestris Viable cells absent in 1 g’
(5) the entry for ‘E 440 (i) PECTIN’ is replaced by the following:
‘E 440 (I) PECTIN
Synonyms
Definition Pectin consists mainly of the partial methyl esters of polygalacturonic acid and
their ammonium, sodium, potassium and calcium salts. It is obtained by
extraction in an aqueous medium of strains of appropriate edible plant material,
usually citrus fruits or apples. The final product must not show any residual
enzyme activity. No organic precipitant shall be used other than methanol,
ethanol and propan-2-ol.
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OJ L, 29.1.2026
Einecs 232-553-0
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 65 % of galacturonic acid on the ash-free and anhydrous
basis after washing with acid and alcohol
Description White, light yellow, light grey or light brown powder
Identification
Solubility Dispersible in water forming a colloidal, opalescent dispersion. Insoluble in
ethanol.
Purity
Loss on drying Not more than 12 % (105 °C, 2 hours)
Acid insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basis
Nitrogen content Not more than 1,0 % after washing with acid and ethanol
Total insolubles Not more than 3 %
Solvent residues Not more than 1 % of free methanol, ethanol and propan-2-ol, singly or in
combination, on the volatile matter-free basis
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,3 mg/kg (only if added to foods for infants and young
children)
Not more than 1 mg/kg (for all uses except for foods intended for infants and
young children)
Mercury Not more than 0,1 mg/kg
Cadmium Not more than 0,1 mg/kg (only if added to foods for infants and young
children)
Not more than 0,5 mg/kg (for all uses except for foods intended for infants and
young children)
Aluminium Not more than 120 mg/kg (only if added to foods for infants and young
children)
Not more than 200 mg/kg (for all uses except for foods intended for infants and
young children)
Microbiological criteria
Enterobacteriaceae Absent in 10 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Escherichia coli Absent in 10 g
Salmonellaspp. Absent in 25 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Cronobacterspp. (Enterobacter Absent in 10 g (only if added to dried infant formulae and dried foods for
sakazakii) special medical purposes intended for infants below 6 months of age)’
ELI: http://data.europa.eu/eli/reg/2026/196/oj 15/18EN
OJ L, 29.1.2026
(6) the entry for ‘E 440 (ii) AMIDATED PECTIN’ is replaced by the following:
‘E 440 (II) AMIDATED PECTIN
Synonyms
Definition Amidated pectin consists mainly of the partial methyl esters and amides of
polygalacturonic acid and their ammonium, sodium, potassium and calcium
salts. It is obtained by extraction in an aqueous medium of appropriate strains
of edible plant material, usually citrus fruits or apples and treatment with
ammonia under alkaline conditions. The final product must not show any
residual enzyme activity. No organic precipitant shall be used other than
methanol, ethanol and propan-2-ol.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 65 % of galacturonic acid on the ash-free and anhydrous
basis after washing with acid and alcohol
Description White, light yellow, light greyish or light brownish powder
Identification
Solubility Dispersible in water forming a colloidal, opalescent dispersion. Insoluble in
ethanol.
Purity
Loss on drying Not more than 12 % (105 °C, 2 hours)
Acid-insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Degree of amidation Not more than 25 % of total carboxyl groups
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basis
Nitrogen content Not more than 2,5 % after washing with acid and ethanol
Total insolubles: Not more than 3 %
Solvent residues Not more than 1 % of methanol, ethanol and propan-2-ol, singly or in
combination, on a volatile matter-free basis
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,3 mg/kg (only if added to foods for infants and young
children)
Not more than 1 mg/kg (for all uses except for foods intended for infants and
young children)
Mercury Not more than 0,1 mg/kg
Cadmium Not more than 0,1 mg/kg (only if added to foods for infants and young
children)
Not more than 0,5 mg/kg (for all uses except for foods intended for infants and
young children)
Aluminium Not more than 120 mg/kg (only if added to foods for infants and young
children)
Not more than 200 mg/kg (for all uses except for foods intended for infants and
young children)
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OJ L, 29.1.2026
Microbiological criteria
Enterobacteriaceae Absent in 10 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Escherichia coli Absent in 10 g
Salmonellaspp. Absent in 25 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Cronobacterspp. (Enterobacter Absent in 10 g (only if added to dried infant formulae and dried foods for
sakazakii) special medical purposes intended for infants below 6 months of age)’
(7) the entry for ‘E 1450 STARCH SODIUM OCTENYL SUCCINATE’ is replaced by the following:
‘E 1450 STARCH SODIUM OCTENYL SUCCINATE
Synonyms SSOS
Definition Starch sodium octenyl succinate is a modified starch. It is manufactured by
treatment of a slurry of food starch with octenylsuccinic anhydride. After the
appropriate extent of esterification is achieved, the modified starch is recovered
by neutralisation with acid, washing with water, dewatering and drying.
Einecs
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
Microscopic observation Passes test (if not pregelatinised)
Iodine staining Passes test (dark blue to light red colour)
Purity
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Octenylsuccinyl groups Not more than 3 % (on an anhydrous basis)
Octenylsuccinic acid residue Not more than 0,3 % (on an anhydrous basis)
Sulphur dioxide Not more than 10 mg/kg on the anhydrous basis
Arsenic Not more than 0,05 mg/kg (on an anhydrous basis) (only if added to foods for
infants and young children)
Not more than 0,1 mg/kg (on an anhydrous basis) (for all uses except for foods
intended for infants and young children)
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OJ L, 29.1.2026
Lead Not more than 0,03 mg/kg (on an anhydrous basis) (only if added to foods for
infants and young children)
Not more than 0,2 mg/kg (on an anhydrous basis) (for all uses except for foods
intended for infants and young children)
Mercury Not more than 0,05 mg/kg (on an anhydrous basis)
Cadmium Not more than 0,01 mg/kg (on an anhydrous basis) (only if added to foods for
infants and young children)
Not more than 0,1 mg/kg (on an anhydrous basis) (for all uses except for foods
intended for infants and young children)
Gluten Gluten free, only in infant formula and follow-on formula, in accordance with
Commission Delegated Regulation (EU) 2016/127(*)
Microbiological criteria
Enterobacteriaceae Absent in 10 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Escherichia coli Absent in 10 g (only if added to foods for infants)
Salmonellaspp. Absent in 25 g (only if added to dried infant formulae, dried foods for special
medical purposes intended for infants below 6 months of age and dried
follow-on formulae)
Cronobacterspp. (Enterobacter Absent in 10 g (only if added to dried infant formulae and dried foods for
sakazakii) special medical purposes intended for infants below 6 months of age)
_____________
(*) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU)
No 609/2013 of the European Parliament and of the Council as regards the specific compositional and
information requirements for infant formula and follow-on formula and as regards requirements on
information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1, ELI: http://data.europa.eu/eli/
reg_del/2016/127/oj).’.
18/18 ELI: http://data.europa.eu/eli/reg/2026/196/oj