EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 13.7.2017  
C(2017) 4864 final 
  
COMMISSION NOTICE 
of 13.7.2017 
relating to the provisi on of information on substances or produ cts causing allergies or 
intolerances as listed in Annex II of Regulation (EU) No 1169/2 011 on the provision of 
food information to consumers 
  
2 
 TABLE OF CONTENTS  
  1.
 INTRODUCTION  .............................................................. .......................................................... 3  
2. LIST OF ALLERGENS (ANNEX II OF REGULATION (EU)  NO 1169/2011) ................................... 3  
3. MODALITIES FOR THE PROVISIONS OF ALLERGEN INFORMATION FOR PRE -PACKED FOODS (IN 
PARTICULAR ARTICLE 21, READ IN CONJUNCTION WITH ARTICLE 18 OF THE REGULATION ) 4 
3.1 When the food bears a list of ingredients ..................... ........................................... 4  
3.2 In the absence of a list of ingredients ....................... ................................................ 6  
3.3 Labelling of derivates from the same allergen ................. ....................................... 6  
3.4 Exemption ................................................. ............................................................... ..... 7  
3.5 Voluntary repetition ...................................... ...............................................................  7 
4. ALLERGEN INFORMATION FOR NON -PREPACKED FOODS  .......................................................... 8  
5. UPDATING OF ANNEX II ............................................................ ............................................... 8   
 
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  1. Introduction 
 
1. This Notice is intended to assist businesses and national autho rities in the application 
of the new requirements of Re gulation (EU) No 1169/2011 related  to the indication of 
the presence of certain substan ces or products causing allergie s or intolerances (Article 
9(1), point c) and Annex II  of the Regulation). 
 
2. Regulation (EU) No 1169/20111 on the provisions of food information to consumers 
(“the Regulation”) lays down new requirements on allergen label ling compared to the 
former Directive 2000/13/EC2.  
 
3. In particular, under the new legislation it is required that th e information on the 
presence of allergens in foods is always provided to the consum ers, including on non-
prepacked foods (Article 9(1), point c) and Article 44). The Me mber States are 
however allowed to adopt nationa l measures concerning the means  through which 
information on allergens on non-prepacked foods is to be made a vailable. With regard 
to the prepacked foods, the Regulation lays down the modalities  defining how the 
information on allergens has to be provided on foods (Article 2 1). Consequently, the 
existing Guidelines on allergen labelling drafted under the reg ime of Directive 
2000/13/EC needs be updated as a reflection of this change in t he law.  
 
4. This Notice is without prejudice to the interpretation which th e Court of Justice of the 
European Union may provide. 
2. List of allergens (Annex II of Regulation (EU) No 1169/2011)  
 
5. Annex II of the Regulation includes a list of food substances o r products causing 
allergies or intolerances. Thi s list has been established on th e basis of the scientific 
opinions adopted by the Europea n Food Safety Authority (EFSA)3. 
6. In the context of Annex II, t he following should be noted: 
• "Cereals" as listed in Annex II, point 1 are to be understood a s an exhaustive list. 
• "Egg" in Annex II, point 3 refers to eggs from all farmed birds .  
• "Milk" in Annex II, point 7 refers to milk from the mammary gla nd of farmed animals.  
• "Nuts" as listed in Annex II, poi nt 8 are to be understood as a n exhaustive list.  
                                                 
1 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 
the 
provision of food information to consumers, amending Regulation s (EC) No 1924/2006 and (EC) No 
1925/2006 of the European Parliament and of the Council, and re pealing Commission Directive 87/250/EEC, 
Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European 
Parliament and of the Council, Commission Directives 2002/67/EC  and 2008/5/EC and Commission 
Regulation (EC) No 608/2004, OJ L 304, 22.11.2011, p. 18. 
2 Directive 2000/13/EC of the European Parliament and of the Coun cil of 20 March 2000  on the approximation 
of the laws of the Member States relating to the labelling, pre sentation and advertising of foodstuffs, OJ L 109, 
6.5.2000, p. 29. 
3 http://www.efsa.europa .eu/EFSA/Scientific_Opinion/opinion_nda_0 4_en1,1.pdf   
 
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  • Annex II lists not only substances and products mentioned as su ch therein but also 
products thereof. In the case where microorganisms have been fe d on a substrate 
which is a food ingredient included in Annex II, those microorg anisms should not be 
considered as products deriv ed from these substrates.  
3. Modalities for the provisions of allergen information for pr e-packed 
foods (in particular Article 21, read in conjunction with Artic le 18 of the 
Regulation) 
 
7. According to Article 21(1), point a):  
 
"Without prejudice to the ru les adopted under Article 44(2), the particulars referred to 
in point (c) of Article 9(1) sha ll meet the following requirements: 
 
a) they shall be indicated in the list of in gredients in accordance with the rules laid 
down in Article 18(1), with a clear reference  to the name of the substance or product 
as listed in Annex II; (…)" 
3.1 When the food bears a list of ingredients  
 
8. In the case of cereals containing gluten listed in Annex II: wh ere ingredients are 
produced from cereals containing gluten, they have to be declar ed under a name 
making a clear reference to the s pecific type of the cereal, i. e. wheat, rye, barley, oats.  
For example:  barley  malt vinegar, oats flakes. 
9. Where "spelt", "khorasan" or "durum" is used, a clear reference  to the specific type of 
the cereal, i.e. "wheat" is required. The word 'wheat' may be a ccompanied by the word 
"durum", "spelt" or "khorasa n", added on a voluntary basis.  
For example:  wheat or wheat (durum) or durum wheat, 
  wheat or wheat (spel t) or spelt wheat. 
10. The indication of a specific type  of the cereal may be accompan ied by the word 
‘gluten’, added on a voluntary basis. 
 For example: wheat flour (contai ns gluten) or wheat flour (glu ten). 
11. Where gluten is added as such, as an ingredient, the type of th e cereal the gluten is 
coming from has to be indicated.   For example: gluten (wheat), w heat gluten or gluten (from wheat ) 
dextrin (wheat) or (wheat gluten ); dextrin (contains wheat) or (contains 
wheat gluten).  
 
5 
  12. When a product containing one of the cereals mentioned in Annex  II (e.g. oats) meets 
the relevant requirements of Regulation (EU) No 828/2014
4, then the statement 
"gluten-free" or "very low gluten" can be used on the product. However, the cereal 
mentioned in Annex II has to still be indicated and emphasised in the list of 
ingredients in accordance with Articles 9 and 21 of the Regulat ion. 
13. In the case of nuts, the specific type as listed in point 8 of the Annex II have to be 
indicated in the list of ingredients, i.e. almonds, hazelnuts, walnuts, cashews, pecan 
nuts, Brazil nuts, pistachio nuts, macadamia or Queensland nuts . Where ingredients or 
processing aids derived from nut s listed in Annex II have been used, the ingredient has 
to be indicated with a clear ref erence to the specific name of the nut.  
For example: flavourings (almond). 
14. According to Article 21(1), point  b) of the Regulation: 
"Without prejudice to the rules adopted under Article 44(2), the particulars referred to 
in point (c) of Article 9(1) sha ll meet the following requirements: 
(…) (b) the name of the substance or product as  listed in Annex II shall be emphasised 
through a typeset that clearly di stinguishes it from th e rest of the list of ingredients, 
for example by means of the font , style or background colour."  
 
15. Article 21(1), point b) gives ce rtain flexibility as regards th e means for ensuring this 
emphasis, for example by means of the font, style or background  color. It is left to the 
food business operator to choose the appropriate manner of diff erentiating the allergen 
concerned from the rest of the list of ingredients. However, so me clarifications are 
needed concerning what information has to be emphasized.  
16. When the name of an ingredient consists of several separate wor ds (e.g. "poudre de 
lait", "latte in polvere"), it is sufficient to only emphasise the word that corresponds to 
the substance/product listed in Annex II. When the name of an i ngredient includes the 
name of an allergen in a single word (e.g. the German word “Mil chpulver” for “milk 
powder”), it is sufficient to emphasise the part of the name of  the ingredient that 
corresponds to the substance/ product listed in Annex II.  
17. If a compound ingredient contains  substances causing allergies or intolerances listed in 
Annex II, those substances have  to be emphasise d in the list of  ingredients. 
For example: in the case of  banana filling containing egg yolk s, strawberry, sugar, 
water,(…), the word "egg" has to be emphasised. In the case of a sandwich with 
mayonnaise made of eggs, the pres ence of "eggs" has to be empha sised.  
                                                 
4  Commission Implementing Regulation (EU) No 828/2014 of 30 Jul y 2014 on the requirements for the 
provision of information to consumers on the absence or reduced  presence of gluten in food, OJ L 228, 
31.7.2014, p. 5.  
 
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  3.2 In the absence of a list of ingredients 
 
18. Article 21(1), second subpara graph provides that: 
 
"In the absence of a list of ingredients, the indication of the particulars referred to in 
point (c) of Article 9(1) shall comprise the word "contains" followed by the name of 
the substance or product as listed in Annex II." 
 
19. In the case of foods exempted from  the obligation to bear the l ist of ingredi ents (such 
as wine) but used as an ingredient in the manufacture or prepar ation of another food 
for which the list of ingredients is provided, the allergens pr esent in that food have to 
be emphasised in order to distinguish them from the rest of the  list of ingredients 
(Article 21(1) applies).  
For example: ingredients: … wine (contains sulphites) where the  word "sulphites" is 
emphasised.  
3.3 Labelling of derivates from the same allergen 
 
20. Article 21(1), third subpar agraph provides that: 
 
"Where several ingredients or processing aids of a food originate from a single 
substance or product listed in Annex II, th e labelling shall make it clear for each 
ingredient or processing aid concerned."  
21. For the purpose of this requireme nt, the reference to the subst ance(s) or product(s) 
listed in Annex II must not necessarily be repeated as many tim es as these substances 
are present. Any presentation ma king clear that different ingre dients originate from a 
single substance or product included in Annex II, would fulfil the requirement and 
would be acceptable. The reference must, however, always be dir ectly linked to the 
list of ingredients, e.g. by placing the referred information a t the end of the list of 
ingredients or in close  proximity to the lis t of ingredients.  
For example:  
A food including food additives, carriers and processing aids d erived from wheat 
could be labelled as follows:  
“…  
- Additive (1)  - Additive (1)  - Carrier (1)  - Processing aid (1)  - …”   
(1) from wheat (where "wh eat" has to be emphasised).  
 
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  3.4 Exemption  
 
22. Article 21(1), last  subparagraph provides that: 
"The indication of the particulars referred to in point (c) of Article  9(1) shall not be 
required in cases where the name of the food clearly refers to the substance or product 
concerned." 
 
23. According to this requirement, where a food is sold under a nam e such as "cheese", 
"cream" which clearly refers to one of the allergens listed in Annex II (e.g. milk) and 
for which it is not required to b ear a list of ingredients purs uant to Article 19(1), point 
d) of the Regulation, the allergen in question does not have to  be indicated on the 
label.  
24. However if such food is sold under  a trade mark / brand name wh ich as such does not 
clearly refer to one of the allergens of Annex II, the name con cerned should be 
supplemented by additional information which provides the "clea r reference" to the 
allergen concerned as requeste d by Article 21(1), last subparag raph. 
For example:  
 
“Ambert” (as the name of the food) together with “farmhouse blu e cheese”  (as 
additional text to the name of the food, displayed in close pro ximity to the name of the 
food), where cheese is the clear  reference to the substance in Annex II.  
As the consumer understanding of the name of the foods in quest ion is likely to vary 
among Member States, an assessment on a case-by-case basis is n ecessary.  
 
25. If the name of the food clearly refers to one of the allergens listed in Annex II and that 
food provides a list of ingredients (no matter whether on a vol untary or mandatory 
basis), the allergen present i n that food has to be emphasised in the list of ingredients.  
For example:  "Cheese (milk, sa lt, rennet, …)" where milk is em phasized. 
     
26. In the case where the name of the food on a product clearly ref ers to a substance or 
product of Annex II but the product also contains other substan ces or products from 
Annex II, those allergens must be indicated to enable consumers  to make informed 
food choices which are safe for them.  
3.5 Voluntary repetition 
 
27. Without prejudice to existing Un ion provisions applicable to sp ecific foods5, it is not 
possible to voluntarily repeat t he allergen inf ormation outside  the list of ingredients; or 
using the word "contains" followed by the name of the substance  or products listed in 
Annex II; or using symbols or  text boxes (see Recital 47, Artic le 21(1) read in 
conjunction with Article 36(1) of the Regulation). 
                                                 
5 Such as provisions of Article 51(2) of Regulation (EC) No 607/ 2009 laying down certain detailed rules for the 
implementation of Council Regulation (EC) No 479/2008 as regard s protected designations of origin and 
geographical indications, traditional terms, labelling and pres entation of certain wine sector products.  
 
8 
   
4. Allergen information for non-prepacked foods 
 
28. Article 44 of Regulation (EU) No 1169/2011 states: 
 
"1. Where foods are offered for sale to the fin al consumer or to ma ss caterers without 
prepackaging, or where foods are packed on the sales premises at the consumer’s request or prepacked for direct sale:  
(a) the provision of the particulars specified in point (c) of Article 9(1) is mandatory;  
(…) 2. Member States may adopt national measur es concerning the means through which 
the particulars or elements of those particu lars specified in paragraph 1 are to be 
made available and, where appropriate, thei r form of expression and presentation." 
 
29. The Regulation provides for mandato ry allergen information for non-prepacked foods.  
30. Member States remain competent to adopt national provision on t he means through 
which allergen information is to be made available on such food s. In principle all 
means of communication as regards the provision of allergen inf ormation, are allowed 
to enable the consumer to make an informed choice, e.g. a label , other accompanying 
material, or any other means including modern technology tools or verbal 
communication (i.e. verifiab le oral information).  
31. In the absence of those national measures, the provisions of th e Regulation concerning 
prepacked food are applicable to non-prepacked food. Accordingl y, in accordance 
with Article 13 of the Regulation the information about allerge ns must be easily 
visible, clearly legible and, wh ere appropriate, indelible and be provided in a written 
form. Therefore, it is not possible to provide allergen informa tion only upon request 
by the consumer. Furthermore, the labelling requirements laid d own in Article 21 of 
the Regulation apply (points 3 – 21 above). 
5. Updating of Annex II  
 
32. Article 21(2) of the R egulation states: 
 
"In order to ensure better information for consumers and to take account of the most 
recent scientific progress and techni cal knowledge, the Commission shall 
systematically re-examine and, where neces sary, update the list in Annex II by means 
of delegated acts, in accordance with Article 51. (…)"  
33. The update of the list in Annex II may consist in adding a subs tance to the list or 
removing a substance from that list. With regard to the deletio n from the list of food  
 
9 
  allergens, Directive 2000/13/EC
6 had provided specific provisions according to which 
interested parties could submit to the Commission studies demon strating that for 
certain allergens it has been scientifically established that i t is impossible to cause 
adverse reactions. These specific  provisions have not been main tained in the 
Regulation. This however does not  prevent potentially intereste d parties to 
communicate to the Commission evidence establishing that produc ts derived from 
substances listed in Annex II are not likely, under certain cir cumstances, to trigger 
adverse reactions i n individuals.  
 
34. Such submissions may be prepared in accordance with the EFSA “G uidance on the 
preparation and presentation of applications pursuant to Articl e 6 paragraph 11 of 
Directive 2000/13/EC”7 and sent to the Commission in, at least, two copies on 
electronic support (CD’s or mem ory sticks) at the following add ress: 
 
Directorate General for H ealth and Food Safety, Unit E1 
European Commission  B-1049 Brussels BELGIUM 
                                                 
6 See Article 6(11), second subparagraph of Directive 2000/13/EC  on the labelling, presentation and 
advertising of foodstuffs, OJ L 109, 6.5.2000, p. 29. 
7 EFSA Journal 2013;11(10):3417