# L_2013202EN.01001101.xml

| 27.7.2013 | EN | Official Journal of the European Union | L 202/11 |
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27.7.2013

EN

Official Journal of the European Union

L 202/11

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COMMISSION REGULATION (EU) No 724/2013

of 26 July 2013

amending Regulation (EU) No 231/2012 as regards specifications on several polyols

(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 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) | Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. |
| --- | --- |

(1)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

| (2) | Those specifications 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. |
| --- | --- |

(2)

Those specifications 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.

| (3) | On 29 November 2011 an application was submitted for the amendment of specifications concerning several polyols which was subsequently made available to the Member States. |
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(3)

On 29 November 2011 an application was submitted for the amendment of specifications concerning several polyols which was subsequently made available to the Member States.

| (4) | Regulation (EU) No 231/2012 lays down specifications for Mannitol (E 421(i)) and Mannitol manufactured by fermentation (E 421(ii)). In order to achieve more clarity and coherence, the currently authorised food additive ‘Mannitol (E 421(i))’ should be renamed as ‘Mannitol by hydrogenation and consequently its definition should be altered. Therefore, the specifications for that food addive should be amended. |
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(4)

Regulation (EU) No 231/2012 lays down specifications for Mannitol (E 421(i)) and Mannitol manufactured by fermentation (E 421(ii)). In order to achieve more clarity and coherence, the currently authorised food additive ‘Mannitol (E 421(i))’ should be renamed as ‘Mannitol by hydrogenation and consequently its definition should be altered. Therefore, the specifications for that food addive should be amended.

| (5) | Isomalt (E 953) is manufactured in a two-stage process in which sugar is first transformed into isomaltulose and then hydrogenated. The crystalline form is obtained by a drying process afterwards. A request was made to include a different form of isomalt, aqueous solutions of isomalt, in the specifications laid down by Regulation (EU) No 231/2012. The proposed form complies with those specifications and is available for commercial use. That form of isomalt is cost-saving and time-efficient for the industry and is consequently of interest, for example, to confectionery manufacturers. Therefore, the description of Isomalt (E 953) in the specifications should be amended. |
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(5)

Isomalt (E 953) is manufactured in a two-stage process in which sugar is first transformed into isomaltulose and then hydrogenated. The crystalline form is obtained by a drying process afterwards. A request was made to include a different form of isomalt, aqueous solutions of isomalt, in the specifications laid down by Regulation (EU) No 231/2012. The proposed form complies with those specifications and is available for commercial use. That form of isomalt is cost-saving and time-efficient for the industry and is consequently of interest, for example, to confectionery manufacturers. Therefore, the description of Isomalt (E 953) in the specifications should be amended.

| (6) | The specifications laid down by Regulation (EU) No 231/2012 provide that one of the purity criteria for polyols is the level of demineralisation or residual minerals, characterised by chlorides, sulphates and/or sulphated ashes. The same polyols are used as excipients for pharmaceutical products, and the European Pharmacopoeia have adopted conductivity as the method to evaluate the level of demineralisation of polyols. By doing so, a triple measure (of chlorides, sulphates and/or sulphated ashes) was replaced by a single one, simpler to carry out, cost-effective and more friendly to the environment. Therefore, specifications should be amended for the food additives Sorbitol (E 420 (i)), Sorbitol syrup (E 420 (ii)), Mannitol (E 421 (i)), Mannitol manufactured by fermentation (E 421 (ii)), Isomalt (E 953), Maltitol (E 965 (i)), Maltitol syrup (E 965 (ii)), Xylitol (E 967) and Erythritol (E 968) by deleting the criteria on chlorides, sulphates and sulphated ashes and replacing them with a single criterion, conductivity. |
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(6)

The specifications laid down by Regulation (EU) No 231/2012 provide that one of the purity criteria for polyols is the level of demineralisation or residual minerals, characterised by chlorides, sulphates and/or sulphated ashes. The same polyols are used as excipients for pharmaceutical products, and the European Pharmacopoeia have adopted conductivity as the method to evaluate the level of demineralisation of polyols. By doing so, a triple measure (of chlorides, sulphates and/or sulphated ashes) was replaced by a single one, simpler to carry out, cost-effective and more friendly to the environment. Therefore, specifications should be amended for the food additives Sorbitol (E 420 (i)), Sorbitol syrup (E 420 (ii)), Mannitol (E 421 (i)), Mannitol manufactured by fermentation (E 421 (ii)), Isomalt (E 953), Maltitol (E 965 (i)), Maltitol syrup (E 965 (ii)), Xylitol (E 967) and Erythritol (E 968) by deleting the criteria on chlorides, sulphates and sulphated ashes and replacing them with a single criterion, conductivity.

| (7) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives, except where the update in question is not liable to have an effect on human health. Since the updates concerned are not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority. |
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(7)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives, except where the update in question is not liable to have an effect on human health. Since the updates concerned are not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority.

| (8) | Regulation (EU) No 231/2012 should therefore be amended accordingly. |
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(8)

Regulation (EU) No 231/2012 should therefore be amended accordingly.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, |
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(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EU) No 231/2012 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in the Member States.

Done at Brussels, 26 July 2013.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  
  OJ L 83, 22.3.2012, p. 1.

3

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ANNEX

The Annex to Regulation (EU) No 231/2012 is amended as follows:

| (1) | In the entry for food additive E 420 (i) Sorbitol, the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Water content | Not more than 1,5 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose on dry weight basis) |
| Total sugars | Not more than 1 % (expressed as glucose on dry weight basis) |
| Nickel | Not more than 2 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis)’ |

(1)

In the entry for food additive E 420 (i) Sorbitol, the specifications as regards purity are replaced by the following:

‘Purity

Water content

Not more than 1,5 % (Karl Fischer Method)

Conductivity

Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

Reducing sugars

Not more than 0,3 % (expressed as glucose on dry weight basis)

Total sugars

Not more than 1 % (expressed as glucose on dry weight basis)

Nickel

Not more than 2 mg/kg (expressed on dry weight basis)

Arsenic

Not more than 3 mg/kg (expressed on dry weight basis)

Lead

Not more than 1 mg/kg (expressed on dry weight basis)’

| (2) | In the entry for food additive E 420 (ii) Sorbitol syrup, the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Water content | Not more than 31 % (Karl Fischer Method) |
| Conductivity | Not more than 10 μS/cm (on the product as such) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose on dry weight basis) |
| Nickel | Not more than 2 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis)’ |

(2)

In the entry for food additive E 420 (ii) Sorbitol syrup, the specifications as regards purity are replaced by the following:

‘Purity

Water content

Not more than 31 % (Karl Fischer Method)

Conductivity

Not more than 10 μS/cm (on the product as such) at temperature 20 °C

Reducing sugars

Not more than 0,3 % (expressed as glucose on dry weight basis)

Nickel

Not more than 2 mg/kg (expressed on dry weight basis)

Arsenic

Not more than 3 mg/kg (expressed on dry weight basis)

Lead

Not more than 1 mg/kg (expressed on dry weight basis)’

| (3) | The entry for food additive E 421(i) Mannitol is amended as follows:






  (a) | the heading is replaced by the following:

  ‘
  E 421 (i) MANNITOL BY HYDROGENATION’ |
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(3)

The entry for food additive E 421(i) Mannitol is amended as follows:

(a)

the heading is replaced by the following:

‘
  E 421 (i) MANNITOL BY HYDROGENATION’

| (b) | the definition is replaced by the following:






  ‘Definition | Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose.
  The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D- Glucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0,1 % of each.’ |
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(b)

the definition is replaced by the following:

‘Definition

Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose.

The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D- Glucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0,1 % of each.’

| (c) | the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Water content | Not more than 0,5 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose) |
| Total sugars | Not more than 1 % (expressed as glucose) |
| Nickel | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg’ |

(c)

the specifications as regards purity are replaced by the following:

‘Purity

Water content

Not more than 0,5 % (Karl Fischer Method)

Conductivity

Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

Reducing sugars

Not more than 0,3 % (expressed as glucose)

Total sugars

Not more than 1 % (expressed as glucose)

Nickel

Not more than 2 mg/kg

Lead

Not more than 1 mg/kg’

| (4) | In the entry for food additive E 421(ii) Mannitol manufactured by fermentation the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Arabitol | Not more than 0,3 % |
| Water content | Not more than 0,5 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose) |
| Total sugars | Not more than 1 % (expressed as glucose) |
| Lead | Not more than 1 mg/kg’ |

(4)

In the entry for food additive E 421(ii) Mannitol manufactured by fermentation the specifications as regards purity are replaced by the following:

‘Purity

Arabitol

Not more than 0,3 %

Water content

Not more than 0,5 % (Karl Fischer Method)

Conductivity

Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

Reducing sugars

Not more than 0,3 % (expressed as glucose)

Total sugars

Not more than 1 % (expressed as glucose)

Lead

Not more than 1 mg/kg’

| (5) | The entry for food additive E 953 Isomalt is amended as follows:






  (a) | the specification as regards description is replaced by the following:






  ‘Description | Odourless, white, slightly hygroscopic, crystalline mass or aqueous solution with a minimum concentration of 60 %’ |
| --- | --- | --- | --- |

(5)

The entry for food additive E 953 Isomalt is amended as follows:

(a)

the specification as regards description is replaced by the following:

‘Description

Odourless, white, slightly hygroscopic, crystalline mass or aqueous solution with a minimum concentration of 60 %’

| (b) | the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Water content | Not more than 7 % for solid product (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| D-Mannitol | Not more than 3 % |
| D-Sorbitol | Not more than 6 % |
| Reducing sugars | Not more than 0,3 % (expressed as glucose on dry weight basis) |
| Nickel | Not more than 2 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis)’ |

(b)

the specifications as regards purity are replaced by the following:

‘Purity

Water content

Not more than 7 % for solid product (Karl Fischer Method)

Conductivity

Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

D-Mannitol

Not more than 3 %

D-Sorbitol

Not more than 6 %

Reducing sugars

Not more than 0,3 % (expressed as glucose on dry weight basis)

Nickel

Not more than 2 mg/kg (expressed on dry weight basis)

Arsenic

Not more than 3 mg/kg (expressed on dry weight basis)

Lead

Not more than 1 mg/kg (expressed on dry weight basis)’

| (6) | In the entry for food additive E 965 (i) Maltitol, the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Appearance of the aqueous solution | The solution is clear and colourless |
| Water content | Not more than 1 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,1 % (expressed as glucose on an anhydrous basis) |
| Nickel | Not more than 2 mg/kg (expressed on anhydrous basis) |
| Arsenic | Not more than 3 mg/kg (expressed on anhydrous basis) |
| Lead | Not more than 1 mg/kg (expressed on anhydrous basis)’ |

(6)

In the entry for food additive E 965 (i) Maltitol, the specifications as regards purity are replaced by the following:

‘Purity

Appearance of the aqueous solution

The solution is clear and colourless

Water content

Not more than 1 % (Karl Fischer Method)

Conductivity

Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

Reducing sugars

Not more than 0,1 % (expressed as glucose on an anhydrous basis)

Nickel

Not more than 2 mg/kg (expressed on anhydrous basis)

Arsenic

Not more than 3 mg/kg (expressed on anhydrous basis)

Lead

Not more than 1 mg/kg (expressed on anhydrous basis)’

| (7) | In the entry for food additive E 965 (ii) Maltitol syrup, the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Appearance of the aqueous solution | The solution is clear and colourless |
| Water content | Not more than 31 % (Karl Fischer Method) |
| Conductivity | Not more than 10 μS/cm (on the product as such) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose on an anhydrous basis) |
| Nickel | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg’ |

(7)

In the entry for food additive E 965 (ii) Maltitol syrup, the specifications as regards purity are replaced by the following:

‘Purity

Appearance of the aqueous solution

The solution is clear and colourless

Water content

Not more than 31 % (Karl Fischer Method)

Conductivity

Not more than 10 μS/cm (on the product as such) at temperature 20 °C

Reducing sugars

Not more than 0,3 % (expressed as glucose on an anhydrous basis)

Nickel

Not more than 2 mg/kg

Lead

Not more than 1 mg/kg’

| (8) | In the entry for food additive E 967 Xylitol, the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Water content | Not more than 1 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,2 % (expressed as glucose on dry weight basis) |
| Other polyhydric alcohols | Not more than 1 % (expressed on dry weight basis) |
| Nickel | Not more than 2 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis)’ |

(8)

In the entry for food additive E 967 Xylitol, the specifications as regards purity are replaced by the following:

‘Purity

Water content

Not more than 1 % (Karl Fischer Method)

Conductivity

Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

Reducing sugars

Not more than 0,2 % (expressed as glucose on dry weight basis)

Other polyhydric alcohols

Not more than 1 % (expressed on dry weight basis)

Nickel

Not more than 2 mg/kg (expressed on dry weight basis)

Arsenic

Not more than 3 mg/kg (expressed on dry weight basis)

Lead

Not more than 1 mg/kg (expressed on dry weight basis)’

| (9) | In the entry for food additive E 968 Erythritol, the specifications as regards purity are replaced by the following:






  ‘Purity |
| --- | --- |
| Loss on drying | Not more than 0,2 % (70 °C, 6 hours, in a vacuum desiccator) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing substances | Not more than 0,3 % expressed as D-glucose |
| Ribitol and glycerol | Not more than 0,1 % |
| Lead | Not more than 0,5 mg/kg’ |

(9)

In the entry for food additive E 968 Erythritol, the specifications as regards purity are replaced by the following:

‘Purity

Loss on drying

Not more than 0,2 % (70 °C, 6 hours, in a vacuum desiccator)

Conductivity

Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

Reducing substances

Not more than 0,3 % expressed as D-glucose

Ribitol and glycerol

Not more than 0,1 %

Lead

Not more than 0,5 mg/kg’

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