EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10069/2018 
(POOL/E1/2018/10069/10069 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
providing derogations from Article 1(3) of Regulation (EC) No 1924/2006 of the 
European Parliament and of the Council on nutrition and health claims made on food 
for the use of certain generic descriptors  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
providing derogations from Article 1(3) of Regulation (EC) No 1924/2006 of the 
European Parliament and of the Council on nutrition and health claims made on food 
for the use of certain generic descriptors  
(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 1924/2006 of the European Parliament and of the 
Council of 20 December 2006 on nutrition and health claims made on foods1, and in 
particular Article 1(4) thereof , 
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 , any claim made on food  which states, 
suggests or implies that a relationship exists between a food category, a food or one of 
its constituents and health is to be considered as a health claim and therefore must 
comply with th at Regulation.  
(2) Article 1(4) of Regulation (EC) No 192 4/2006 provides  for a possible  derogation from 
the rules applicable pursuant to Article 1(3) of that Regulation  for generic descriptors 
(denominations) which have traditionally been used to indicate a particularity of a 
class of foods or beverages  which could imply an effect on human health.  
(3) Applications for a term to be used as generic descriptor may be submitted by food 
business operators to the national competent authority of a recipient Member State.  
(4) Pursuant to Commission Regulation (EU) No 907/2013 setting the rules for 
applications concerning the use of generic descriptors (denominations)2, a valid 
application should be transmitted to the Commission and to all Member States; 
Member States concerned by the application shall provide the Commission wit h their 
opinions thereon.  
(5) Following receipt of a  valid  application  and the opinions of Member States concerned 
the Commission may initiate the procedure of approval of the generic descriptor 
pursuant to Article 1(4) of Regulation (EC) No 1924/2006 . 
(6) On 13 A pril 2015, the Austrian competent authority provided the Commission with an 
application from the Austrian Food Industries' Association, submitted pursuant to 
Article 1(4) of Regulation (EC) No 1924/2006, for the terms 'Hustenbonbon' and 
'Hustenstopper' to be used as generic descriptors in Austria.  
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 Commission Regulation (EU) No 907/2013 of 20 September 2013 setting up the rules for applications 
concerning the use of generic descriptors (denominations), ( OJ L 251, 21.9.2013, p. 7 ).   
EN 2  EN (7) On 13 April 2015, the Austrian competent authority provided the Commission with an 
application from Drapal GmbH, submitted pursuant to Article 1(4) of Regulation (EC) 
No 1924/2006, for the term 'Hustenzuckerl' to be used as generic descriptor in Austria.  
(8) On 19 May 2015, the German competent authorit y provided the Commission with an 
application from the Association of the German Confectionary Industry, submitted 
pursuant to Article 1(4) of Regulation (EC) No 1924/20 06, for the term 'Brust -
Caramellen’ to be used as generic descriptors in Germany and in Austria.  
(9) On 29 May 2015, the German competent authorit y provided the Commission with an 
application from SOLDAN Holding + Bonbonspezialitäten GmbH and from the 
Associat ion of the German Confectionery Industry , submitted pursuant to Article 1(4) 
of Regulation (EC) No 1924/2006, for the term  'Hustenmischung' to be used as generic 
descriptor in Germany.  
(10) On 8 June 2015, the German competent authorit y provided the Commission with an 
application from SOLDAN Holding + Bonbonspezialitäten GmbH , submitted pursuant 
to Article 1(4) of Regulation (EC) No 1924/2006, for the term  'Hustenperle'  to be used 
as generic descriptor  in Germany.  
(11) On 18 June 2015, the German competent authorit y provided the Commission with two 
application s from SOLDAN Holding + Bonbonspezialitäten GmbH  and the 
Association of the German Confectionery Industry , submitted pursuant to Article 1(4) 
of Regulation (EC) No 1924/2006, for the terms  'Halsbonbon' and 'Keelp astille' to be 
used as generic descriptors  in Germany ('Halsbonbon') and in the Netherlands 
('Keelpastille').  
(12) On 18 November 2015, the German competent authorit y provided the Commission 
with three  application s from SOLDAN Holding + Bonbonspezialitäten GmbH , Josef 
Mack  GmbH & Co. KG and the  Association of the German Confectionery Industry, 
submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the terms 
'Hustenbonbon' , 'Hoestbonbon', 'rebucados para a tosse', and 'cough drops', to be used 
as generic descriptors  in Germany and in Austria ( 'Hustenbonbon' ), in the Netherlands 
('Hoestbonbon'), in Portugal ('Rebucados para a tosse') and in the United Kingdom 
('Cough drops') . 
(13) The Austrian and German competent authorities provided all other Member S tates 
with the applications. The competent authorities of Member States concerned provided 
the Commission with their opinions on the applications.  
(14) The terms 'Hustenbonbon' , ‘Hustenstopper’, 'Hustenzuckerl', ‘Brust -Caramellen’, 
'Hustenmischung', 'Hustenperl e' ‘Halsbonbon’, ‘Keelpastille’, 'Hoestbonbon', 
'rebucados para a tosse', and 'cough drops' fall into the scope of Regulation (EC) 
No 1924/2006, because they can imply a relationship between the foods bearing these 
terms and health.  
(15) However, evidence has been provided that these terms have been traditionally used in 
Germany and in Austria (‘Hustenbonbon’, ‘Brust -Caramellen’), in Germany 
(‘Halsbonbon’, 'Hustenmischung' and 'Hustenperle'), in Austria (‘Hustenstopper’ and 
'Hustenzuckerl'), in the Netherlands (‘Keelpastille’, and ‘Hoestbonbon’), in Portugal 
('rebucados para a tosse') and in the United Kingdom (‘cough drops’) in the meaning 
of Article 1(4) of this Regulation, as generic descriptors to describe a class of sweets 
based on sugars as well as sugar -free and calorie -reduced variants based on sweeteners 
(polyols and/or intense sweeteners) containing extracts of herbs , fruit or other plant 
substances , such as menthol , honey or malt.   
EN 3  EN (16) In particular, the terms ‘Hustenbonbon’, ‘Brust -Caramellen’, ‘Halsbonbo n’, 
'Hustenmischung', 'Hustenperle' ,‘Hustenstopper’, 'Hustenzuckerl', ‘Keelpastille’, 
'Hoestbonbon’, 'rebucados para a tosse' and 'cough drops' have neither been used in 
Germany, in Austria, in the Netherlands, in Portugal and in the United Kingdom 
respec tively, with the aim to indicate a health effect of this class of food nor are 
understood by an average consumer as claiming a health effect of this class of food.  
(17) Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the 
use of the generic descriptors ‘Hustenbonbon’ and ‘Brust -Caramellen’ in Germany 
and in Austria, 'Halsbonbon', 'Hustenmischung' and 'Hustenperle' in Germany, 
‘Hustenstopper’ and 'Hustenzuckerl' in Austria, ‘Keelpastille’ and ‘Hoestbonbon’ in 
the Netherlands, 'rebucado s para a tosse' in Portugal and ‘cough drops’ in the United 
Kingdom when used in the respective Member State on sweets based on sugars as well 
as sugar -free and calorie -reduced variants based on sweeteners (polyols and/or intense 
sweeteners) containing ext racts of herbs , fruit or other  plant substances, honey or malt.  
(18) On 12 January 2017, the Finnish competent authorit y provided the Commission with 
an application from the Finnish Food Industries' Association, submitted pursuant to 
Article 1(4) of Regulation (EC) No 1924/2006, for the term 'Kurkkupastilli/ 
Halspastill' to be used as generic descriptor in Finland.  
(19) The Finnish competent authorit y provided all other Member States with the 
application; it also provided the Commission with its opinion on the applic ation.  
(20) The term 'Kurkkupastilli/ Halspastill' falls into the scope of Regulation (EC) 
No 1924/2006, because it can imply a relationship between foods bearing this term 
and health. However, evidence has been provided that this term has been used 
traditional ly in Finland, in the meaning of Article 1(4) of this Regulation, as generic 
descriptor to describe a class of sweets based on sugars as well as sugar -free and 
calorie -reduced variants based on sweeteners (polyols and/or intense sweeteners) . 
(21) In particular,  the term 'Kurkkupastilli/ Halspastill' has neither been used in Finland 
with the aim to indicate a health effect of this class of food nor is understood by an 
average consumer as claiming a health effect of this class of food.  
(22) Derogation from Regulation ( EC) No 1924/2006 should therefore be granted for the 
use of the generic descriptor 'Kurkkupastilli/ Halspastill' when used in Finland on hard 
sweets based on sugars as well as sugar -free and calorie -reduced variants based on 
sweeteners (polyols and/or inte nse sweeteners) .  
(23) On 13 April 2015, the Austrian competent authority provided the Commission with an 
application from Drapal GmbH, submitted pursuant to Article 1(4) of Regulation (EC) 
No 1924/2006, for the term 'Hustensirup' to be used as generic descript or in Austria.  
(24) The Austria n competent authority  provided all other Member States with the 
application; it also provided the Commission with its opinion on the application.  
(25) The term 'Hustensirup' falls into the scope of Regulation (EC) No 1924/2006, because  
it can imply a relationship between foods bearing this term and health. However, 
evidence has been provided that this term has been used traditionally in Austria, in the 
meaning of Article 1(4) of this Regulation, as generic descriptor to describe a class  of 
confectionery products made of solutions of sugar, starch syrup, inverted sugar and/or 
honey with the addition of herbal ingredients, 'Hustensirup' referring to a class of 
products in the form of a syrup.   
EN 4  EN (26) In particular, the term 'Hustensiup' has neither been used with the aim to indicate a 
health effect of this class of food nor is understood by an average consumer as 
claiming a health effect of this class of food in Austria.  
(27) Derogation from Regulation (EC) No 1924/2006 should therefore be granted  for the 
use of the generic descriptor 'Hustensirup' when used in Austria on confectionery 
products made of solutions of sugar, starch syrup, inverted sugar and/or honey with 
the addition of herbal ingredients in the form of syrup.  
(28) Definitions for sugars intended for human consumption have been laid down in point  
A of the Annex to Council Directive 2001/111/EEC of 20 December 2001 relating to 
certain sugars intended for human consumption3. In order to ensure legal certainty, 
those definitions should also apply for the purpose of this Regulation.  
(29) On 2 April 2015, the UK competent authorit y provided the Commission with an 
application from the British Soft Drinks Association, submitted pursuant to Article 
1(4) of Regulation (EC) No 1924/2006, for the term 'tonic' (in English) used as part of 
the descriptive name of a beverage in the form of 'tonic w ater', 'Indian tonic w ater' or 
'quinine tonic w ater' and also substituting  the word 't onic' (in English) with 'tonique ' 
(in French), 'tónico ' or 'tonica ' (in Italia n, Spanish, and Portuguese ), 'tονωτικό ' or 
'tonotikó ' (in Greek), 't onik' (in Croatian, Czech, Hungarian, Polish,  Slovak  and 
Slovenian), 'тоник ' (in Bulgarian),  to be used as generic descriptor in all Member 
States except in Romania.  
(30) On 30 September 2015, the Romanian competent authorit y provided the Commission 
with an application from the Romanian  Soft Drinks Association, submitted pursuant 
Article 1(4) of Regulation (EC) No 1924/2006, for the term  'tonic' (in English) used as 
part of the descriptive name of a food in the form of 'tonic water', 'Indian tonic water' 
or 'quinine tonic water' and also substituting the word 'tonic'  (in English)  with 'tόnico', 
'tonică ' or 'tonica ' (in Romanian ), to be used as generic descriptor  in Romania . 
(31) The UK competent authority and the Romanian competent authority provided all other 
Member States with the applications; Member States have provided the Commission 
with their opinions on these applications.  
(32) The Greek competent authorit y consider that the t erm 't ονωτικό ' is considered as a 
health claim within the meaning of Regulation (EC) No 1924/2006.  
(33) The German competent authorit y and the Austrian competent authority consider that 
the term 'tonic' used as part of 'tonic water'. 'Indian tonic water' or 'qu inine tonic water' 
is part of a customary name of the food and as such out of the scope of Regulation 
(EC) No 1924/2006.  
(34) Certain competent authorities consider that when the term 'tonic' (in English) is 
substituted by 't onotikó ' (in Greek)  it is not an exa ct translation, and when the term 
'tonic' is substituted by 't onik' in Croatian, Hungarian, Polish and Slovenian,  it is not 
considered as a health claim in th ose respective Member State s within the meaning of 
Regulation (EC) No 1924/2006; therefore in thei r views these terms are out of the 
scope of the Regulation.  
(35) The term 'tonic' and the equivalent linguistic forms, namely, 'tonique', 'tonik' , 'tόnico' , 
'tónica' and 'tonică  ' , when they are used as part of the descriptive name of a beverage,  
fall into the  scope of Regulation (EC) No 1924/2006 , because they can imply a 
relationship between a food bearing this term and health. However, evidence has been 
                                                 
3 OJ L 10, 12.1.2002, p. 53.   
EN 5  EN provided that th ese terms have been used traditionally, in the meaning of Article 1(4) 
of this Regulation, as generic descriptor s to describe a class of beverages, namely, a 
non-alcoholic carbonated beverage containing the bittering agent quinine  in the form 
of the flavourings FL 14.01 1, FL 14.152 or 14.155 as referred to in the Union list of 
flavourings laid down in Regulation (EC) No 1334/2008  on flavourings and certain 
food ingredients with flavouring properties for use in and on foods4.  
(36) In particular, t he terms 'tonic' and the equi valent linguistic forms, namely, 'tonique', 
'tonik' , 'tόnico' , 'tónica' and 'tonică  ', when they are used as part of the descriptive name 
of a beverage,  have neither been used with the aim to indicate a health effect of this 
class of beverages nor are unde rstood by an average consumer as claiming a health 
effect of this class of beverages . 
(37) Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the 
use of the generic descriptor  'tonic'  (in English),  when used as part of the descriptive 
name of a non -alcoholic carbonated beverage containing the bittering agent  quinine  in 
the form of the flavourings FL 14.011, FL 14.152 or 14.155 as referred to in the Union 
list of flavourings as laid down in Regulation (EC) No 1334/2008. The term 'tonic' (in 
English) may be replaced by  'тоник ' (in Bulgarian),  'tonik' (in Czech and in Slovak),  
'tonique' (in French), 'tó nica' (in Spanish) 'tonica' (in Italian and in Portuguese) ,or 
'tonică'  (in Romanian).  
(38) On 23 April 2015, the Italian competent authorit y provided the Commission with an 
application from Monviso S.P.A., submitted pursuant to Article 1(4) of Regulation 
(EC) No 1924/2006, for the term 'biscotto salute' to be used as generic descriptor in 
Italy and in Malta.  
(39) The Italian competent authority pro vided all other Member States with the application; 
the Member States concerned have provided the Commission with their opinions on 
the application.  
(40) The term 'biscotto salute' falls into the scope of Regulation (EC) No 1924/2006, 
because it can imply a rel ationship between a food bearing this term and health. 
However, evidence has been provided that this term has been used traditionally in 
Italy, in the meaning of Article 1(4) of this Regulation, as a generic descriptor to 
describe a class of rusk -type bake ry products.  
(41) In particular, the term 'biscotto salute' has neither been used with the aim to indicate a 
health effect of this class of foods nor is understood by an average consumer as 
claiming the health effect of this class of food in Italy.  
(42) Malta indic ated that the term 'biscotto salute' was not used to describe rusk -type 
bakery products on the Maltese market.  
(43) Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the 
use of the generic descriptor 'biscotto salute' when used in Ita ly on rusk -type bakery 
products.  
(44) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plants, Animals, Food and Feed , 
                                                 
4 Regulation (EC) No 1334/2008 of the European Parliament and of th e Council of 16 December 2008 on 
flavourings and certain food ingredients with flavouring properties for use in and on foods and 
amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 
and Directive 2000/13/EC ( OJ L 354, 31.12.20 08, p. 34 ).  
EN 6  EN HAS ADOPTED THIS REGULATION:  
Article 1 
The generic descriptors listed in the Annex  to this Regulation are  exempted from the 
application of Article 1(3) of Regulation (EC) No 1924/2006  under the conditions laid down 
in that Annex . 
Article 2  
For the purposes of this Regulation, the definitions for sugars intended for human 
consumption lai d down in point A of the Annex to Council Directive 2001/111/EEC shall 
apply.  
Article 3  
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 all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER