2011/0156(COD): Extra info

This article provides additional information for the article “Threat of European ban on ‘gluten free’ labelling of regular consumer foods”.


I was led to write these articles after reading the following news article by Allergenen Consultancy, a consultancy firm specialized in allergen issues in the food industry:

‘Gluten free’ no longer allowed on regular food

Last week, the European Parliament has [adopted its position] on a new Regulation on food intended for infants and young children and on food for special medical purposes (2011/0156(COD)). This Regulation will withdraw the ‘gluten free Regulation 2009/41’.

[…]An important change implemented by the European Parliament is the addition of a new condition (article 8a) that the marking ‘gluten free’ in word or image may no longer be used on food for normal consumption. This also means that the gluten free icon is not allowed on products that are naturally gluten free, but only on dietetic products. […]

http://www.allergenenconsultancy.nl/nieuws.php?nid=149, June 18, 2012.

A similar news item can be found in the July 2012 newsletter of WFC Food Safety.

The September 2012 issue of the Dutch Celiac Society’s (NCV) Glutenvrij Magazine (vol. 39, nr. 3, p. 30-31) also ran an article on the new regulation. It touches upon the new requirements for the use of a “gluten free” marking, but the possible reduction of choice of gluten-free normal foods is not mentioned.


With this article I aim to answer the following questions:

  1. Will “gluten free” disappear from regular food?
  2. How did this proposal come about?
  3. Is there any room for change?

1. Will “gluten free” disappear from regular food?


Currently, the composition and labelling of foodstuffs for people intolerant to gluten (e.g. celiacs) is governed by Regulation (EC) 41/2009. Among other things, this regulation sets a gluten content limit of 20 mg/kg for usage of the term “gluten free” (art. 3).

Regulation (EC) 41/2009 is primarily concerned with “foodstuffs for particular nutritional uses”, meaning food specially made for people intolerant to gluten (art. 2 (a)). However, article 4 also allows the use of “gluten free” on “foodstuffs for normal consumption”, as long as the same norm of 20 mg/kg is adhered to. With this the distinction between “food for particular nutritional use” and “food for normal consumption” disappears when it comes to the use of the “gluten free” mark.

On to the new proposal. Legislative procedure 2011/0156(COD) is a proposal for a Regulation on food intended for infants and young children, on food for special medical purposes, on food for people intolerant to gluten and on food intended for use in low and very low calorie diets. Words in italic have been added by the European Parliament. At this moment, the consolidated version of the European Parliament, first reading, June 14, 2012 is the most recent draft of the regulation, leading to the aforementioned articles by Allergenen Consultancy, WFC Food Safety and Glutenvrij Magazine. When answering the question if the “gluten free”-marking on normal foods is indeed threatened, I will be using that same version.

The proposal seeks to abolish the concept of “foodstuffs for particular nutritional uses”, because experience had shown that no clear distinction could be made with “foodstuffs for normal consumption” (recitals 8 through 13).

As a result, the proposal seeks to merely set additional requirements for some specific categories within the generic group of “foodstuffs”. However, when choosing these categories (food for babies and the sick) the principle seems unchanged: food specially made for vulnerable groups. According to the European Parliament, gluten intolerant people are a vulnerable group comparable with babies and people suffering from illness, and therefore food for this group has been added to the proposal as a separate category.

The proposal sets specific composition and information requirements for the different categories. In return, products produced according to these requirements gain an exclusive right to the marking “specialized nutrition”. This is accomplished by prohibiting the use of the expression “specialized nutrition” on food for normal consumption (article 8a (a)). The proposal does not give a definition for “food for normal consumption”, but we may assume that it encompasses all the other foodstuffs, i.e. the foods not in one of the special categories of this regulation.

Article 8a (b) also prohibits for this group:

all other markings or any presentation likely to give the impression that the food belongs to one of the categories referred to in Article 1(1).

Article 1(1) mentions under (ca):

food for people intolerant to gluten

This term is further defined in article 2(2) (hb):

foodstuffs for particular nutritional uses which are specially produced, prepared or processed to meet the special dietary needs of people intolerant to gluten;

According to recital 4 of the proposal, “foodstuffs for particular nutritional uses” is defined by Directive 2009/39/EC (art. 1):

2. Foodstuffs for particular nutritional uses are foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability.

3. A particular nutritional use shall fulfil the particular nutritional requirements: […] of certain categories of persons [whose/who are …]

So, foods that are not “foodstuffs for particular nutritional uses specially made for people intolerant to gluten” are not allowed to “give the impression” that they are.

Give the impression that they are

Is a “gluten free” label merely informative or does it also give the impression that the product is in the category “foodstuffs for particular nutritional uses specially made for people intolerant to gluten”?

Article 10a(2) on the “gluten free” label:

Food intended for people intolerant to gluten sold to the final consumer which contain a level of gluten:


– not exceeding 20 mg/kg may be labelled ‘gluten free’.

Should we reason ‘e contrario‘ that other food is not allowed to use this label, or is it possible that other, future regulation will allow food for normal consumption to also use the “gluten free” label, in the way that article 4 of Regulation (EC) 41/2009 did? The parliament has chosen the first option, judging by recital 26:

Those statements [‘gluten free’] should be regulated solely by this Regulation and comply with requirements herein. Regulation (EC) No 41/2009 should therefore be repealed.

Note the word “solely”: Beforehand, the parliament already excludes the possibility to regulate the “gluten free” marking in another regulation as well.

Even if food for normal consumption would be allowed to use the “gluten free” statement, the problem would arise that by repealing Regulation (EC) 41/2009 the uniform meaning of this term – the limit of 20 mg/kg gluten content – is lost. The term is re-defined for special foods, but not for “normal” foods.

2. How did this proposal come about?

The legislative process of 2011/0156(COD) is tracked by PreLex, OEIL and the Montesqiueu Institute. Here we look at the steps already taken:

Proposal European Commission: Transfer the gluten free-rules

On June 20, 2011 the European Commission adopted a “Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and on food for special medical purposes (COM/2011/0353, COM 353/2011, 2011/0156(COD))”. This proposal included the repeal of Regulation (EC) 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. The preamble of the proposal recited that these rules should be transferred to Regulation (EC) 1924/2006 (on nutrition and health claims made on foods) and that this transfer should be finished before the proposed regulation (2011/0156(COD)) would enter into application.

This is, of course, a strange setup: A new law is proposed in which an old law is repealed. However, the new law does not cover the topic previously covered by the old law, other than stating that this topic should be regulated by another new law before the first new law comes into force. Who, when and how is unclear and this is how the trouble started.

Italian Senate

In an opinion by the Italian Senate of September 30, 2011, the Senate points out that with the newly proposed regulation the old Regulation (EC) 41/2009, concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten, is repealed. The Italian Senate feels that this is an infringement of the principles of subsidiarity and proportionality. In other words: Brussels is overstepping its boundaries.

Consideration by the European Parliament

Search the Register of Documents of the European Parliament for the terms “2011/0156(COD)” or “gluten”. It seems that the (draft) agendas normally appear in the register one or two weeks before the meeting. In the plenary sitting of July 5, 2011 the consideration of the proposal within the parliament was referred to the ENVI Committee (Environment, Public Health and Food Safety).

Consideration by the ENVI Committee

Use this search engine to search the documents of the ENVI Committee. Within the ENVI Committee, Frédérique Ries (Belgium, ALDE) was appointed Rapporteur for this proposal. On November 30, 2011 she submitted a Draft report, containing 56 amendments on the European Commission’s proposal. Other ENVI Committee members tabled another 226 amendments (No. 57 through 167 and No. 168 through 282) to the draft report. The ENVI Committee voted on these amendments on February 29, 2012, after which Ries adapted her report.

In the final Report, Amendment 56 proposes to introduce article 8a:

In the labelling, presentation and advertising of food for normal consumption the following shall be prohibited:

(a) the use of the expression ‘specialised nutrition’, either alone or in conjunction with other words, to designate such food;

(b) all other markings or any presentation likely to give the impression that the food belongs to one of the categories referred to in Article 1(1) .

Amendment 56 seems to be intended to counter market practices related to foods for babies and young children, where products are incorrectly marketed as being more healthy for children or specially made for children.

At the same time, some amendments were included to bring “gluten free” in the scope of this regulation, such as Amendment 35 to add to article 1(1):

(ca) food for people intolerant to gluten.

The files of the ENVI Committee contain the amendments to the Draft report, that are numbered differently from the amendments in the Final report. These files show that amendments 35 and 56 of the Report originated from several identical amendments to the Draft report, tabled by various MEPs:

  • Amendment 35 of the Report (extending the scope of the Regulation to food for people intolerant to gluten) corresponds with Amendments 130 through 132 and 135 to the Draft Report. These were tabled by Italian and German members: Elisabetta Gardini (Italy, EPP), Paolo Bartolozzi (Italy, EPP), Sergio Berlato (Italy, EPP), Lorenzo Fontana (Italy, EFD), Cristiana Muscardini (Italy, EPP), Oreste Rossi (Italy, EFD), Andrea Zanoni (Italy, ALDE), Patrizia Toia (Italy, S&D), Antonio Cancian (Italy, EPP), Amalia Sartori (Italy, EPP), Mario Pirillo (Italy, S&D), Tiziano Motti (Italy, EPP), Salvatore Tatarella (Italy, EPP), Lara Comi (Italy, EPP), Anja Weisgerber (Germany, EPP), Renate Sommer (Germany, EPP).
  • Amendment 56 of the Report (prohibiting certain designations on food for normal consumption) corresponds with Amendments 177 through 181 to the Draft report.
  • Amendment 70 of the Report (new requirements for the use of “gluten free”) corresponds with Amendment 231 to the Draft report, tabled by rapporteur Ries.

The minutes of the ENVI Committee meeting of February 29, 2012 are also available and show the results of the votes per amendment to the Draft report.

All amendments regarding gluten free seem to have been grouped in one block C4. I have not been able to find exactly which amendments were included in this block. A further distinction is made between two blocks: GLUTEN 1 and GLUTEN 2, but I have also not been able to discover the contents of these block. The minutes state that the amendments were tabled by the parties ALDE, EPP, S&D and Greens. The plus-sign (+) on the right means that the block of amendments was adopted.

Rapporteur Ries implemented the amendments on her Draft report into a final Report of April 26, 2012. In an explanatory statement on her Report she states to prefer to regulate “gluten free” in another regulation:

Legal cover for people with a food intolerance

Another of the key aspects of this proposal is the incorporation of Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten into the legislative framework for nutrition and health claims made on foods (Regulation (EC) No 1924/2006).


With a view to clarifying this grey area, the rapporteur considers that it would be more appropriate to incorporate the rules governing statements relating to gluten and lactose into the new Regulation (EU) No 1169/2011 on food labelling. Article 36 of this cross-cutting regulation already provides for the possibility of laying down criteria relating to information on the presence of products causing allergies.

The other Regulation she is referring to is Regulation (EU) No 1169/2011, that will govern the provision of food information to consumers from 2014. For both prepacked as non-prepacked foods the provision of allergen information will become mandatory. Article 36 regards the voluntary provision of allergen information.

Sitting of the European Parliament: No real debate

The report by Ries was debated in the plenary sitting of the European Parliament of June 14, 2012.

General comments on the debate:

  • A true debate is not reached. Incidentally, a “blue card” question is asked, but lack of a real answer does not result in any follow-up questions.
  • At this point, the ENVI Committee already has a common standpoint. Several members refer to a compromise, of which “gluten free” also seems to have been a part.
  • All speakers are eager to say that they want to help that “vulnerable group” of celiac patients. No lack of good intentions.
  • The provisional minutes only mention the names of the speakers. Refer to the extended minutes to see the contributions of the various speakers in the original languages. A video of the debate with simultaneous interpretation in English and other languages is also available.
  • The simultaneous interpretation with the video does not always correctly render what is being said. The minutes in the language of the speaker form a better rendition, although even here some words differ from the words actually spoken.

First the opening speech by rapporteur Ries, who refers to the interests of the diet food industry:

“[…] we need to think about some dynamic companies in Europe, these SMEs which make up the really creative and innovative heart of Europe when it comes to new products and job creation. Whether it be companies in Italy or Germany working in the gluten free field, […]”

– Frédérique Ries (Belgium, ALDE), Rapporteur ENVI Committee European Parliament on 2011/0156(COD), June 14, 2012 (minutes in French, video with English interpretation clip from 9:04:35)

Note that the amendments in the ENVI Committee on the addition of “gluten free” to this regulation were also from Italian and German origin (see before) and that Ries now points to the interests of companies in the gluten free industry in those very countries.

The European Commission states that the addition of gluten free foods in this regulation is unnecessary and not in the interest of celiacs. European Commissioner Dalli is present at the debate and states that regulation (EU) 1169/2011 is more suitable for regulating ‘gluten free’:

“However, my support cannot extend to the inclusion of gluten-free foods within the scope of the regulation. This, in our view, is unnecessary and would be in line neither with the interest of coeliacs, for whom these products are intended, nor with the principles of better regulation and simplification.

We all agree on the importance of maintaining the existing rules on such foods. But this can be ensured in a simpler and better way by transferring these rules to the recently adopted Regulation on Food Information to Consumers. In addition, such a transfer would guarantee that the existing rules would also apply to non-prepacked foods and would consequently offer higher and broader protection to coeliacs.”

– John Dalli, European Commissioner, June 14, 2012 (minutes in English, video in English clip from 9:08:45)

This stance is identical to the stance of the Council of the European Union (=Council of Ministers), as well as to the preference stated by Ries in the explanatory statements on her Report.

Subsequently, ENVI members of various parties speak:

De Lange (The Netherlands, EPP) states that she wants to include gluten free in this regulation because the Commission did not regulate this subject under the general food regulation yet:

“We need to look at gluten as well, because it was not sufficiently clear when the Commission would consider that this falls under normal foodstuffs and that legislation.”

– Esther de Lange (The Netherlands, EPP), June 14, 2012 (minutes in Dutch, video with English interpretation clip from 9:15:15)

The compromise is already starting to show some cracks. Girling clearly sees the problem and implies that the only effect is a protection for “certain manufacturers in certain countries”:

“So I will talk about the issues that I did not sign up to in the compromise. The first was the proposal on gluten-free. I certainly do not believe that the proposal that we have come up with in committee makes it easier for consumers. I do not believe it adds anything at all to their safety or to the protection of their vulnerability. It is protecting certain manufacturers in certain countries, and certain national regimes, and we should cut across that.”

– Julie Girling (United Kingdom, ECR), June 14, 2012 (minutes in English, video in English clip from 9:25:00)

Note that before, Girling had tabled an amendment (No. 280) to the Draft report, in which she proposed to regulate “gluten free” for all foodstuffs in Regulation (EU) 1169/2011 (Food Information for Consumers). At the vote on the report in the ENVI Committee meeting of February 29, 2012, at which Girling was absent, her amendment was considered lapsed after the positive vote on including “gluten free” in the proposal 2011/0156(COD). In the end, other members of her party who were present voted in favor of the entire report, such as her fellow countryman and party member Martin Callanan (United Kingdom, ECR).

Liese (Germany, EPP) hints that the celiac-issue also led to discussion within the EPP parliamentary group and that the current stance of the parliament is the result of a compromise:

“I also want to pay tribute to the compromise on the special foods for celiac patients. We discussed this at length in the EPP Group and we believe that it is important to continue to offer special foods here, since it is not only important that these foods are gluten-free – that can also be ensured by the labelling regulation – but also that they are balanced in other regards. If I eat sweets all day, then I have a gluten free diet, but not a healthy diet.”

– Peter Liese (Germany, EPP), June 14, 2012 (minutes in German, video with English interpretation clip from 9:32:25)

Pirillo (Italy, S&D) seems to propose a middle way:

“In future negotiations with the Council a horizontal regulation linking with Regulation (EU) No. 1169/2011 could be proposed. In this case, the general marking “gluten free” must be associated with* the emblem “suitable for coeliacs” for a clear distinction between the allergen-free products and those for proper nutrition.”

– Mario Pirillo (Italy, S&D), June 14, 2012 (minutes in Italiaans, video with English interpretation clip from 9:49:53)

* Anyone speaking Italian, please check the translation. One would expect that he would say “be distinguished from”. However, several simultaneous interpretations, as well as Google Translate, could not give me a definite answer. Even the Italian minutes seem not to be an exact rendition of the words spoken. So here is the audio-clip (MP3, Italian, 22 sec., 373 kB). If you have a better translation, leave a comment at the bottom of the main article.

European Commissioner Dalli defends the stance of the European Commission that “gluten free” has no place in this regulation and again refers this matter to Regulation (EU) 1169/2011 on food information:

“On the issue of gluten-free foods, I believe that we have to remove the perception that our proposal in any way reduces protection for coeliacs. On the contrary, we are increasing protection for coeliacs by maintaining the compositional and labelling rules as they are and transferring those rules to a more appropriate legal text: Food Information to Consumers, which in addition to packed foods will also protect coeliacs in the case of non-packed foods, which will not be the case if we get this piece of legislation within this particular legislation.”

– John Dalli, European Commissioner, June 14, 2012 (minutes in Engels, video in English clip from 10:03:30)

Ries contradicts herself

Rapporteur Ries turns down Dalli’s proposal. She hints on what it lacks according to the parliament, but this does not make it any clearer:

“I conclude with the […] big differences with the Commission, listening to the Commissioner. First, the issue of gluten free products. Many of us here – a majority – believe that the reference in the “Food Information to Consumers” legislation will not be sufficient. This goes beyond issues of labelling. For us, Article 36 of that Regulation is not good enough in terms of quality, safety and composition. But we will come back on that.”

– Frédérique Ries (Belgium, ALDE), Rapporteur ENVI Committee European Parliament on 2011/0156(COD), June 14, 2012 (minutes in French, video with English interpretation clip from 10:07:17)

She seems to be contradicting the aforementioned remarks in her own report. Or is she defending a majority view that she does not share herself?

Explanations of votes

In connection with the plenary vote of June 14, 2012, several MEPs provided explanations of votes (link 1 en link 2). Many MEPs state that by regulating “gluten free” they hope to help the celiac patients, but few seem to be aware of the decision to grant exclusive rights to the diet foods industry.

Below are the explanations of two members that would rather see the subject regulated for all the foodstuffs in Regulation (EU) No 1169/2011 on food labelling:

I support the calls in this report for the regulation of gluten-free products under the existing Food Information to Consumers Regulation.

– Mairead McGuinness (Ireland, EPP)

We would prefer to have ‘gluten-free’ regulated under the general regulation on Food Information to Consumers.

– Raül Romeva i Rueda (Spain, Greens-EFA)

Very few seem to have made a conscious choice to deny normal food the “gluten free” designation:

Celiac disease is a disease and the words “gluten free” on food can not be trivialized as a mere “claim” or allergen.

– Matteo Salvini (Italy, EFD)


Following the debate, there were votes on the amendments proposed in rapporteur Ries’s report, as emerged from the ENVI committee (No. 1 through 82), but also votes on later amendments (No. 83 through 87, No. 88 through 92, No. 93).

Among these later amendments was a new amendment (No. 90) tabled by Frédérique Ries and Esther de Lange on behalf of the ALDE and EPP groups to change recital 26 of the proposed regulation in such a way that “gluten free” is to be solely regulated by this regulation. This seems to a priori exclude any possibility that “gluten free” might also be regulated for food for normal consumption.

Click here for the results of votes and here for a video of the voting.

Amendment 56 (prohibiting certain designations on food for normal consumption) was adopted as part of a set of amendments for which no separate vote was requested.

The conservatives (ECR) did request a separate vote on the gluten-amendments, including No. 35, but in the end these were also adopted (video, from 12:17:00).

Amendment 90, to the effect that “gluten free” will be regulated by this regulation exclusively, was voted upon separately and adopted (video, from 12:21:13).

After all amendments were voted upon, the report and accompanying legislative resolution were adopted by a large majority (video, from 12:21:30), including the prohibition of “gluten free” designations on foodstuffs for normal consumption.

3. Is there any room for change?

In the editorial on this proposed regulation I give some suggestions for improvement and maybe you have some ideas yourself as well. But how much room for change is actually left?

Council of Ministers’ turn

A general description of the ordinary legislative procedure can be found on the website of the Council of the European Union, also known as Council or Council of Ministers, and on the website of the European Parliament. In it we can see that formally, the Council now has to adopt a position at first reading and that it is not bound to any time limits.

Within the Council this subject was already discussed shortly during the meeting of June 7 and 8, 2012 by the configuration Transport, Telecommunications and Energy under the item “FOOD LAW / Foods for vulnerable persons”. At this meeting, the Council agreed on a general approach, which means that internal agreement was reached within the Council.

Council opposed to European Parliament: “Gluten free” to be covered by another regulation

So, what is the position of the Council of Ministers? The press release 10381/12 of June 7, 2012 shows that the Council does not agree with the European Parliament that gluten-free food should be covered by this Regulation:

“Gluten-free” and “very low gluten” food statements should be covered by regulation (EU) 1169/2011 on the provision of food information to consumers. In fact, the purpose of those statements is to provide consumers with information on the absence of an element in the food. Those statements are not intended to give guarantees in terms of the overall composition of the food which, in contrast, is one of the objectives of the proposed regulation.

The press release refers to note 10086/12, as prepared by the Permanent Representatives Committee, which states that the rules regarding the use of the term “gluten free” should be moved to Regulation (EU) 1169/2011 on food information to consumers:

(26) […] For the sake of clarity and consistency, the rules on the use of the statements ‘gluten-free’ and ‘very low gluten’ should also be regulated under Regulation (EU) No 1169/2011. It is necessary that the acts pursuant to Regulation (EU) No 1169/2011, transferring the rules on the use of the statements ‘gluten-free’ and ‘very low gluten’ as regulated under Regulation (EU) No 41/2009 be completed prior to the application of this Regulation.

Source: “A” item note 10086/12, June 1, 2012, recital 26, page 14.

The document also shows that, here again, Italy is opposed.

Parliament and Council negotiations

At present, the following two versions of 2011/0156 (COD) are pitted against each other:

Negotiations between the European Parliament and the Council will start soon. It is not clear to me whether such negotiations are public or not? If you have an answer to this question, please leave a comment below the main article.

Commentary, discussion and taking action

For a commentary and discussion on the proposal, as well as a list of the MEPs involved, see the main article: “Threat of European ban on ‘gluten-free’ labelling of regular consumer foods”.

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