Commission Implementing Regulation (EU) No 1321/2013
of 10 December 2013
establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Article 10(2) of Regulation (EC) No 2065/2003 provides for the initial establishment of a Union list of authorised smoke flavouring primary products (hereinafter referred to as ‘primary products’). That list is to be established on the basis of applications for authorisation submitted by business operators and the opinion issued by the European Food Safety Authority (‘the Authority’) on the relevant primary product.
In accordance with Article 10 of Regulation (EC) No 2065/2003, the Authority received 14 valid applications for authorisation of primary products before 16 June 2005. Three applications have been withdrawn. Therefore the Authority has evaluated in total 11 primary products. One evaluated application has been withdrawn after completion of the evaluation.
According to Article 4(1) of Regulation (EC) No 2065/2003 the authorisation of smoke flavourings may be subject to specific conditions of use and according to Article 9(3) of that Regulation authorisations should be granted for 10 years, renewable in accordance with Article 12 of that Regulation.
Conditions for the production of primary products are laid down in Annex I of the Regulation (EC) No 2065/2003 including maximum content of polycyclic aromatic hydrocarbons.
When authorised smoke flavourings are used in or on food, their use must be in accordance with the conditions of use, including maximum levels, set in the Annex to this Regulation. When authorised smoke flavourings are used in combination, the individual levels should be reduced proportionally.
Smoking by regenerated smoke is a process of treating food by exposing it to smoke which is regenerated by atomizing smoke flavourings in a smoking chamber under the time and temperature conditions similar to those for hot or cold smoking. In that case it is difficult to estimate how much of the smoke flavourings will be present in the final food as marketed due to loss of smoke flavouring during smoking. Therefore, the use should be in accordance with good manufacturing practices.
Unless subject to further restrictions, an authorised smoke flavouring may be present in food, other than by direct addition, as a result of carry-over from an ingredient in which the smoke flavouring was permitted, provided that the level of the smoke flavouring in the final food is no greater than would be introduced by the use of the ingredient under proper technological conditions and good manufacturing practice.
The Union list of smoke flavourings should apply without prejudice to other provisions laid down in sector specific legislation.
Since smoke flavourings are already on the market in the Member States, provisions have been made to ensure that the transition to a Union authorisation procedure is smooth. To this effect transitional periods have been laid down in Article 20 of Regulation (EC) No 2065/2003.
Pursuant to Article 12 of Regulation (EC) No 2065/2003, authorisations are renewable for 10-year periods on application to the Commission by the authorisation holder. The application must be accompanied by the documents listed in Article 12(2) of that Regulation. Those documents must include any available information concerning toxicological data following the advice of Authority given in its guidance document of 7 October 2004 or its latest update.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
The list of the smoke flavouring primary products authorised to the exclusion of all others in the Union for use in or on foods and/or for the production of derived smoke flavourings, as referred to in Article 6 of Regulation (EC) No 2065/2003, is laid down in 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.
The list of the authorised smoke flavourings is established with the effect from 1 January 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 December 2013.
For the Commission
The President
José Manuel Barroso
ANNEXUnion list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings
Note 1:
Maximum levels refer to levels in or on food as marketed. By way of derogation from this principle, for dried and/or concentrated foods which need to be reconstituted the maximum levels shall apply to the food as reconstituted according to the instructions on the label taking into account the minimum dilution factor. If primary products are used for the production of the derived smoke flavourings, the maximum levels shall be adjusted accordingly.
Note 2:
When combinations of smoke flavourings are used in or on foodstuffs, the individual levels shall be reduced proportionally.
Note 3:
In case smoke flavourings are permitted to be used in processed meat (food category 8.2) or in processed fish and fishery products (food category 9.2) and these foods are smoked in a smoking chamber by regenerating smoke by using these permitted smoke flavourings, the use shall be in accordance with good manufacturing practices.
Note 4:The presence of a smoke flavouring shall be permitted:
- (a)
in a compound food other than as referred to in the Annex, where the primary product is permitted in one of the ingredients of the compound food;
- (b)
in a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with this Regulation.
Unique code | SF-001 | |
|---|---|---|
Name of the product | Scansmoke PB 1110 | |
Name of the authorisation holder | Azelis Denmark A/S | |
Address of the authorisation holder | Lundtoftegaardsvej 95 2800 Lyngby DENMARK | |
Description and characterisation of the product | 1.Source materials:90 % beech (Fagus sylvatica), 10 % oak (Quercus alba) 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.7.Cheese and cheese products | 2,0 | |
2.Fats and oils and fat and oil emulsions | 0,002 | |
3.Edible ices | 0,005 | |
5.Confectionery | 0,05 | |
8.1.2.Meat preparations as defined by Regulation (EC) No 853/2004 of the European Parliament and of the Council25
| 2,0 | |
8.2.Processed meat | 2,0 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 2,0 | |
9.3.Fish roe | 2,0 | |
12.2.Herbs, spices, seasonings | 2,3 | |
12.5.Soups and broths | 0,23 | |
12.6.Sauces | 1,0 | |
12.7.Salads and savoury based sandwich spreads | 0,23 | |
14.1.Non-alcoholic beverages | 0,02 | |
14.2.Alcoholic beverages, including alcohol-free and low-alcohol counterparts | 0,02 | |
15.Ready-to-eat savouries and snacks | 2,0 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-002 | |
|---|---|---|
Name of the product | Zesti Smoke Code 10 | |
Name of the authorisation holder | Mastertaste | |
Address of the authorisation holder | Draycott Mills Cam Dursley Gloucestershire GL11 5NA UNITED KINGDOM | |
Description and characterisation of the product | 1.Source material:50 – 60 % of hickory (Carya ovata), 40 – 50 % oak (Quercus alba) 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.7.Cheese and cheese products | 0,5 | |
1.8.Dairy analogues, including beverage whiteners | 0,5 | |
4.2.Processed fruits and vegetables | 0,3 | |
8.1.2.Meat preparations as defined by Regulation (EC) No 853/2004 | 2,5 | |
8.2.Processed meat | 2,5 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 2,0 | |
9.3.Fish roe | 2,0 | |
12.2.Herbs, spices, seasonings | 3,0 | |
12.5.Soups and broths | 0,3 | |
12.6.Sauces | 1,0 | |
12.9.Protein products, excluding products covered in category 1.8 | 1,0 | |
15.Ready-to-eat savouries and snacks | 3,0 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-003 | |
|---|---|---|
Name of the product | Smoke Concentrate 809045 | |
Name of the authorisation holder | Symrise AG | |
Address of the authorisation holder | Mühlenfeldstraße 1 37603 Holzminden GERMANY | |
Description and characterisation of the product | 1.Source material:Beech (Fagus sylvatica) 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.Dairy products and analogue | 0,5 | |
4.2.Processed fruits and vegetables | 0,3 | |
6.4.5.Fillings of stuffed pasta (ravioli and similar) | 1,0 | |
7.1.Breads and rolls | 0,6 | |
7.2.Fine bakery wares | 0,6 | |
8.Meat | 0,6 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 0,6 | |
9.3.Fish roe | 0,6 | |
12.2.Herbs, spices, seasonings | 3,0 | |
12.5.Soups and broths | 0,6 | |
12.6.Sauces | 4,0 | |
12.7.Salads and savoury based sandwich spreads | 1,0 | |
12.9.Protein products, excluding products covered in category 1.8 | 1,0 | |
15.Ready-to-eat savouries and snacks | 3,0 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-004 | |
|---|---|---|
Name of the product | Scansmoke SEF 7525 | |
Name of the authorisation holder | Azelis Denmark A/S | |
Address of the authorisation holder | Lundtoftegaardsvej 95 2800 Lyngby DENMARK | |
Description and characterisation of the product | 1.Source materials:35 % red oak (Quercus rubra), 35 % white oak (Quercus alba), 10 % maple (Acer saccharum), 10 % beech (Fagus grandifolia) and 10 % hickory (Carya ovata). 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.Dairy products and analogue | 0,16 | |
2.Fats and oils and fat and oil emulsions | 0,05 | |
4.2.Processed fruits and vegetables | 0,05 | |
5.Confectionery | 0,08 | |
6.Cereals and cereal products | 0,05 | |
7.1.Breads and rolls | 0,08 | |
7.2.Fine bakery wares | 0,08 | |
8.Meat | 0,16 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 0,16 | |
9.3.Fish roe | 0,16 | |
10.2.Processed eggs and egg products | 0,05 | |
12.2.Herbs, spices, seasonings | 0,18 | |
12.5.Soups and broths | 0,05 | |
12.6.Sauces | 0,05 | |
12.7.Salads and savoury based sandwich spreads | 0,05 | |
12.9.Protein products, excluding products covered in category 1.8 | 0,05 | |
14.1.Non-alcoholic beverages | 0,05 | |
14.2.Alcoholic beverages, including alcohol-free and low-alcohol counterparts | 0,05 | |
15.Ready-to-eat savouries and snacks | 0,08 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-005 | |
|---|---|---|
Name of the product | SmokEz C-10 | |
Name of the authorisation holder | Red Arrow Products Company LLC | |
Address of the authorisation holder | P.O. Box 1537 633 South 20th street Manitowoc, WI 54221- 1537 USA | |
Description and characterisation of the product | 1.Source materials:
2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.7.Cheese and cheese products | 0,2 | |
8.1.2.Meat preparations as defined by Regulation (EC) no 853/2004 | 2,5 | |
8.2.Processed meat | 2,5 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 2,0 | |
9.3.Fish roe | 2,0 | |
12.2.Herbs, spices, seasoning and condiments | 3,0 | |
12.6.Sauces and like products | 3,0 | |
15.Ready-to-eat savouries and snacks | 3,0 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-006 | |
|---|---|---|
Name of the product | SmokEz Enviro-23 | |
Name of the authorisation holder | Red Arrow Products Company LLC | |
Address of the authorisation holder | P.O. Box 1537 633 South 20th street Manitowoc, WI 54221- 1537 USA | |
Description and characterisation of the product | 1.Source materials:
2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.7.Cheese and cheese products | 2,0 | |
8.1.2.Meat preparations as defined by Regulation (EC) no 853/2004 | 5,0 | |
8.2.Processed meat | 5,0 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 2,0 | |
9.3.Fish roe | 2,0 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-007 | |
|---|---|---|
Name of the product | TradismokeTM A MAX | |
Name of the authorisation holder | Nactis | |
Address of the authorisation holder | 36, rue Gutenberg – ZI La Marinière 91070 Bondoufle FRANCE | |
Description and characterisation of the product | 1.Source materials:Beech (Fagus grandifolia) 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.4.Flavoured fermented milk products including heat treated products | 1,0 | |
1.6.3.Other creams | 1,0 | |
1.7.3.Edible cheese rind | 1,0 | |
1.7.5.Processed cheeses | 1,0 | |
2.Fats and oils and fat and oil emulsions | 1,0 | |
8.1.2.Meat preparations as defined by Regulation (EC) No 853/2004 | 4,0 | |
8.2.Processed meat | 4,0 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 4,0 | |
9.3.Fish roe | 4,0 | |
12.2.Herbs, spices, seasonings | 1,0 | |
12.5.Soups and broths | 0,5 | |
12.6.Sauces | 1,0 | |
14.1.Non-alcoholic beverages | 0,1 | |
14.2.Alcoholic beverages, including alcohol-free and low-alcohol counterparts | 0,1 | |
15.Ready-to-eat savouries and snacks | 1,0 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-008 | |
|---|---|---|
Name of the product | proFagus-Smoke R709 | |
Name of the authorisation holder | ProFagus Gmbh | |
Address of the authorisation holder | Uslarer Strasse 30 37194 Bodenfelde GERMANY | |
Description and characterisation of the product | 1.Source materials:90 % beech (Fagus sylvatica), 10 % oak (Quercus alba) 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.7.Cheese and cheese products | 2,5 | |
2.Fats and oils and fat and oil emulsions | 0,002 | |
3.Edible ices | 0,005 | |
4.2.Processed fruits and vegetables | 0,55 | |
5.Confectionery | 0,1 | |
8.1.2.Meat preparations as defined by Regulation (EC) No 853/2004 | 2,5 | |
8.2.Processed meat | 2,5 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 2,5 | |
9.3.Fish roe | 2,5 | |
12.2.Herbs, spices, seasonings | 4,0 | |
12.4.Mustard | 0,1 | |
12.5.Soups and broths | 0,28 | |
12.6.Sauces | 1,5 | |
12.7.Salads and savoury based sandwich spreads | 0,4 | |
14.1.Non-alcoholic beverages | 0,1 | |
14.2.Alcoholic beverages, including alcohol-free and low-alcohol counterparts | 0,02 | |
15.Ready-to-eat savouries and snacks | 2,5 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-009 | |
|---|---|---|
Name of the product | Fumokomp | |
Name of the authorisation holder | Kompozíció Kft | |
Address of the authorisation holder | Kompozíció Kft 2053 Herceghalom HUNGARY | |
Description and characterisation of the product | 1.Source materials:85 % beech (Fagus sylvatica), 15 % hornbeam (Carpinus betulus) 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.4.Flavoured fermented milk products including heat treated products | 0,06 | |
1.6.3.Other creams | 0,06 | |
1.7.Cheese and cheese products | 0,06 | |
1.8.Dairy analogues, including beverage whiteners | 0,06 | |
2.Fats and oils and fat and oil emulsions | 0,06 | |
3.Edible ices | 0,06 | |
4.2.Processed fruit and vegetables | 0,06 | |
5.Confectionery | 0,06 | |
6.3.Breakfast cereals | 0,06 | |
6.4.5.Fillings of stuffed pasta (ravioli and similar) | 0,06 | |
6.5.Noodles | 0,06 | |
6.6.Batters | 0,06 | |
6.7.Pre-cooked or processed cereals | 0,06 | |
7.1.Breads and rolls | 0,06 | |
7.2.Fine bakery wares | 0,06 | |
8.Meat | 0,06 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 0,06 | |
9.3.Fish roe | 0,06 | |
10.2.Processed eggs and egg products | 0,06 | |
12.2.Herbs, spices, seasonings | 0,06 | |
12.3.Vinegar | 0,06 | |
12.4.Mustard | 0,06 | |
12.5.Soups and broths | 0,06 | |
12.6.Sauces | 0,06 | |
12.7.Salads and savoury based sandwich spreads | 0,06 | |
12.9.Protein products, excluding products covered in category 1.8 | 0,06 | |
13.3.Dietary foods for weight control diets intended to replace total daily food intake or an individual meal | 0,06 | |
13.4.Foodstuffs suitable for people intolerant to gluten as defined by Regulation (EC) No 41/200926
| 0,06 | |
14.1.4.Flavoured drinks | 0,06 | |
14.1.5.2.Other | 0,06 | |
14.2.Alcoholic beverages, including alcohol-free and low-alcohol counterparts | 0,06 | |
15.Ready-to-eat savouries and snacks | 0,06 | |
16.Desserts excluding products covered in category 1, 3 and 4 | 0,06 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |
Unique code | SF-010 | |
|---|---|---|
Name of the product | AM 01 | |
Name of the authorisation holder | AROMARCO, s.r.o | |
Address of the authorisation holder | Mlynská 15 929 01 Dunajská Streda SLOVAKIA | |
Description and characterisation of the product | 1.Source materials:Beech (Fagus sylvatica) 2.Specifications:
3.Purity criteria:
| |
Conditions of use | Food category | Maximum level g/kg |
1.4.Flavoured fermented milk products including heat treated products | 0,6 | |
1.6.3.Other creams | 0,6 | |
1.7.Cheese and cheese products | 0,6 | |
1.8.Dairy analogues, including beverage whiteners | 0,6 | |
2.Fats and oils and fat and oil emulsions | 0,4 | |
8.1.2.Meat preparations as defined by Regulation (EC) no 853/2004 | 0,85 | |
8.2.Processed meat | 0,85 | |
9.2.Processed fish and fishery products including crustaceans and molluscs | 0,8 | |
9.3.Fish roe | 0,8 | |
14.2.Alcoholic beverages, including alcohol-free and low-alcohol counterparts | 0,02 | |
15.Ready-to-eat savouries and snacks | 1,3 | |
Date from which the product is authorised | 1 January 2014 | |
Date until which the product is authorised | 1 January 2024 | |