EU ban on “gluten free” averted; delicate subject entrusted to closed committee

The European Parliament agreed to leave the rules on “gluten free” marking out of the special foods regulation after all, averting a ban on the use of “gluten free” markings on normal foods.

The European Commission convinced the European Parliament and the Member States that it will transfer the existing rules on “gluten free” to the 2011 Regulation on Food Information to Consumers without any changes.

The political agreement could be interpreted as leaving the Commission some room for introducing additional requirements for use of the label, even if that would affect celiac consumer choice.

A call for changes could originate from the SCFCAH committee, a powerful, but closed advisory committee of the Commission. This committee will play a key role in the 2013 developments on this issue and is made up of national officials of the various European member states. Dietetic food industry lobbying at these officials might once again lead to surprises.

For example, this blog has discovered that in October 2012, the Italian Celiacs Association AIC had one of its lobbying documents drafted by a dietetic food industry representative. In response, AIC states that in Italy, consumers and the dietetic foods industry were united on this issue. Italian celiacs get their dietetic foods reimbursed from the national health service. AIC states that it has come to accept the political agreement and welcomes the call on the Commission to examine a possible distinction between naturally gluten-free foods and foods rendered gluten-free. For both food categories, AIC now agrees with maintaining the existing requirement of 20 mg/kg, seeking no new, additional requirements at the European level. Instead, AIC intends to use the labeling distinction to set additional requirements for the reimbursement of gluten-free rendered foods at their national level. Italy voted in favor of the agreement.

MEP and shadow rapporteur Esther de Lange (The Netherlands, EPP) says the Commission guaranteed the Parliament that the rules will be transferred without changes. She expects the transfer to be completed early 2014.

Different statements made by Germany during the negotiations indicate that Germany dropped its objections to the “gluten free” part of the deal only at the last moment, though still voting against the entire agreement for other, unrelated reasons.

Contents

History

Commission mistake, wrong fix by European Parliament

(June 2011 – June 2012)

In June 2011, the European Commission proposed a new Regulation on special medical foods, known as COM/2011/0353, COM 353/2011 or 2011/0156(COD). With this proposal, the existing rules on “gluten free” labeling were withdrawn without making clear how this subject would be governed in the future. In June 2012, alerted by Italian and German MEPs, the European Parliament adopted amendments to transfer the “gluten free” rules to the proposed new Regulation.

However, the proposed Regulation in which the European Parliament wanted to include the “gluten free” rules, covers only special foods, such as foods for infants and medical foods. It contains many tough requirements that are completely unrelated to the gluten content of the foods. For example, all “gluten free” labelled foods would have needed to be scientifically and medically reviewed, contain minimum levels of vitamins and minerals and production would have needed to be controlled by an extra quality control system. The proposal further stated that it was the only place for “gluten free” to be regulated. No different rules for food for normal consumption. If the European Parliament’s proposal would have come through, it would have led to supermarkets and producers of regular foods massively removing their “gluten free” markings from their gluten free items.

More details on the June 2011-June 2012 history can be found in my September 2012 articles here and here.

Informal trialogue negotiations

(July 2012 – November 2012)

After the June 2012 adoption of the European Parliament’s first reading of the proposal, it was now formally the Council’s turn to respond. The proposal is in the EU’s so-called ordinary legislative procedure, also called co-decision (COD) procedure, laid down in article 294 Treaty on the Functioning of the EU.

On 6 July 2012, the Council made an examination of the differences it had with the Parliament. With every “gluten”-amendment of the Parliament, the Council remarked “Not acceptable. Incompatible with the approach of regulating gluten free products in the context of Regulation (EU) No 1169/2011.”

But instead of the Council giving a formal response, the parties decided to enter trialogue negotiations.

Trialogue, or trilogue, meetings are a typical European phenomenon, in which representatives from the European Parliament, the Council of the European Union (the member states) and the European Commission negotiate in informal, closed-door meetings to find political agreement on legislative issues. Although trialogues can be very efficient, they also make the legislative process less transparent and less democratic (Farrell and Héritier 2003, Stie 2012).

Many times, trialogue meetings are held before the Parliament’s first reading, leading to a first reading agreement. In this case, an agreement was reached after the Parliament already issued its opinion in first reading, but before the Council adopts its common position. This is called an early second reading agreement (Reh et al., 2011, Articles 16 through 18 Joint declaration on practical arrangements for the codecision procedure).

According to a LIMITE marked document containing an early draft of the political agreement, the first two trialogues took place on 19 September and 9 October 2012. Before the third meeting, an adaption of the “gluten free” Recital 26 was approved at a COREPER meeting of 9 November 2012, with Germany opposed. The political agreement was reached in a third meeting of 14 November 2012, “following long and difficult discussions” and approved formally in December 2012.

Political agreement: “Gluten free” to be governed by general food law

(December 2012 – March 2013)

The new agreement reverses all the “gluten free” amendments that the European Parliament made on the proposal on medical foods and foods for infants, including the ban on “gluten free” labels on food for normal consumption.

The only reference that is made to “gluten free” in the agreement, is in Recital 26. It states that the new act “should ensure at least the same level of protection”. Although this guarantees that the current requirements on “gluten free” marking won’t be loosened, this wording leaves the door open for discussion on additional protective requirements, which could reduce celiac consumer choice.

The agreement was approved by the Committee on Environment, Public Health and Food Safety (ENVI) of the European Parliament on 18 December 2012, at which rapporteur Ries made clear that celiac consumers are not as vulnerable as infants and hospital patients, and will be treated on an equal footing as other consumers:

“We are talking here about foods for special purposes. This is geared towards categories of the population that really need these foods: Children younger than 3 years old, obesity patients and people in hospital for long period.

[…]

The much-debated food intolerances, lactose and gluten intolerances, one of the main topics of the plenary debate, will be covered by Food Information to Consumers (FIC) on a similar basis to what applies to allergens.”

– Frédérique Ries (Belgium, ALDE), Rapporteur ENVI Committee European Parliament on 2011/0156(COD), 18 December 2012 (video with English interpretation clip from 10:11:15)

The Council approved the agreement on 20 December 2012 (video with English interpretation). The text of the Regulation as incorporated in the agreement is now undergoing legal and linguistic verification. Subsequently, it will be formally adopted by the Council in first reading and the Parliament in second reading. As an agreement has now been reached, the formal adoptions are expected to be nodded through by March 2013.

The road ahead

Delegated and implementing acts

The agreement is to regulate “gluten free” in the Food Information to Consumers (FIC) regulation, which governs food for normal consumption. The agreement does not provide details on exactly how this should be done. Several of our sources expect the Commission to transfer the rules the existing regulation on “gluten free” by means of delegated and implementing acts.

These acts are not covered by the same checks and balances as the ordinary legislative procedure. Therefore, delegated acts are normally reserved for changing only non-essential elements of a legislation and implementing acts are normally reserved for implementing measures of a technical and administrative nature only.

Different sources report that the Commission will first use a delegated act to add “gluten free” to Article 36(3) FIC, as foreseen by paragraph 4 of that article. Subsequently, as required by paragraph 3, the Commission needs to adopt an implementing act on the application of the following three requirements of paragraph 2:

“2. Food information provided on a voluntary basis shall meet the following requirements:

(a) it shall not mislead the consumer, as referred to in Article 7;

(b) it shall not be ambiguous or confusing for the consumer; and

(c) it shall, where appropriate, be based on the relevant scientific data.”

– Article 36(2), Regulation (EU) 1169/2011 (FIC)

“Details” left to Commission…

So how should the Commission fill in the details of these abstract requirements? The new agreement gives no decisive answer:

“The acts to be adopted pursuant to Regulation (EU) No 1169/2011, which are to transfer the rules on the use of the statements ‘gluten-free’ and ‘very low gluten’, as contained in Regulation (EC) No 41/2009, should ensure at least the same level of protection for people who are intolerant to gluten as currently provided for under Regulation (EC) No 41/2009.”

– Recital 26, Political agreement on 2011/0156(COD)

On the one hand, the mandate to Commission is limited by the words “which are to transfer”, implying that the Commission is only allowed to transfer the rules, not to change them. Also, a change of the rules might go against the idea that delegated and implementing acts are meant only for non-essential issues.

On the other hand, the words “at least the same level of protection” (underlining added) could be interpreted as allowing the Commission to introduce additional requirements, provided they increase the protection, but regardless of the consequences for producer costs or celiac consumer choice. The recital text does not offer any guarantees in this last regard.

…, which will seek advice from a committee of member state officials

The contents of these delegated and implementing acts will be decided upon in so-called comitology procedures, in which the European Commission is advised by a closed committee consisting of experts sent by the EU member states. Even MEPs are excluded from the meetings, only receiving copies of the proposals made by the European Commission.

With regard to delegated acts, the Lisbon Treaty gave the European Parliament and the Council the right to veto the Commission proposal, but critics call this a theoretical right. Chapter VII of the FIC Regulation allows the Parliament a mere two months to rally an absolute majority (369 of 737 member) on a technical issue like gluten free labeling.

For the implementing act, the FIC Regulation determines that the Commission should follow the examination procedure, by which the Commission may only adopt an implementing act if the Standing Committee on the Food Chain and Animal Health (SCFCAH) delivers a positive opinion.

The committee’s General Food Law section is scheduled to meet five times this year.  Its website shows agendas and summary records, noting some of the thoughts exchanged between the delegations, though not identifying individual member states. Underlying documents, as well as details on who exactly are representing the member states, are available to the European Parliament and the Council, but not to the public.

This committee is composed of representatives of the Member States and chaired by a representative of the Commission. Member states are said to usually send department officials specialized in legislation in the particular field at hand, but may also sometimes choose to send, for example, a university expert. Dietetic food industry lobbying at these officials might once again lead to surprises.

Who are those national officials and how to connect with them?

Although it is not clear who are representing the member states, good starting places to voice your opinion right now would be at the national level:

  • Permanent Representations of the Member States to the European Union: Contact details for country in this document;
  • The relevant Department or Ministry of that member state, for example a Ministry of Food, Health and/or Consumer Affairs;
  • National MPs.

Do you have more information about the SCFCAH committee? Or did you reach out to any of the above-mentioned points of contact? Feel free to share your experiences by leaving a comment below.

Italy

That the interests of “gluten free” consumers of one member state do not always coincide with the interests of “gluten free” consumers in other member states, is shown by the example of Italy.

Italy’s focus on dietetic foods

The Italian position in the labeling debate is ambiguous. In documents and public debates, Italian EU-politicians like to present themselves as champions of celiac protection, using the same slogans as the dietetic food industry, such as “vulnerable group”, “special dietary needs” and “nutritionally adequate”. But with their focus on dietetic foods they seem to disregard the role generally available foods can play in a gluten free diet.

In the second half of 2011, the Italian Senate and Italian MEPs were the first to draw attention to the looming withdrawal of the existing “gluten free”-Regulation. However, they then allowed the European Parliament to adopt an opinion in first reading that would bring back “gluten free” marking of dietetic foods, but make it impossible for normal foods to carry this mark.

The Italian Celiacs Association (AIC) reportedly voted against a September 2012 opinion of the Association of European Coeliac Societies (AOECS), in which AOECS supports, under certain conditions, the proposal of the European Commission to transfer the “gluten free” rules to general food law.

A general explanation for Italy’s position starts with the Italian national health system. Italian celiacs get up to EUR 140 per month of their gluten free dietetic foods reimbursed. This reimbursement scheme alleviates a problem that many other European celiacs have with dietetic foods: the high costs.

But with more and more regular foods carrying the “gluten free” marking, the Italian health insurance is having trouble deciding which gluten free foods to reimburse:

“It appears necessary to revise the register of reimbursable dietetic products for celiacs, whereas rules on the [European] Community level, such as Regulation (EC) 41/2009 under certain conditions allow foods for normal consumption to carry the label “gluten free” as well.”

Outline of the national health plan 2011-2013, Ministry of Health, Italy, page 30 (page 34 of PDF)

Taken together with a sharp increase of diagnosed celiacs in Italy (from 64.000 in 2007 to 135.000 in 2011), an estimated pool of 465.000 undiagnosed celiacs, and Monti’s broad austerity measures also hitting health spending, the additional costs of reimbursing normal foods no doubt threatens Italy’s “gluten free” reimbursement system. Both Italian celiacs and the dietetic foods industry would want to prevent cuts on Italy’s reimbursement system.

Italian diet foods industry in on EU closed-door negotiations

A specific result of this shared interest is this memo of 19 October 2012. It contains suggestions for the new legislation. It was signed by AIC and sent to the European legislators that were negotiating behind supposedly closed doors. However, Microsoft Word document properties show it was originally drafted by the head of supplements and dietary products of the Italian Association of Food Product Industries (AIIPA).

AIC memo to EU legislators of 19 October 2012 shows AIIPA representative as original author

As AIIPA was not mentioned in the text of the memo itself, it is likely that the EU legislators who received AIC’s opinion were not aware of the AIIPA involvement.

The memo proposed to add the following text to Recital 26 of the proposed legislation, suggesting that celiacs cannot live without foods specially made for them:

(26) Foods that have been formulated, processed or prepared to meet the special dietary needs of people intolerant to gluten are a consistent source of nourishment of this vulnerable group of the population. Such foods are vital for the management of coeliac disease, as gluten free diet is the only treatment for this pathology. Coeliacs require foods that are specially formulated to help them in the dietary management of their specific condition. […]

Proposed text in AIIPA drafted, AIC signed memo to EU legislators of 19 October 2012.

This text did not make it into the political agreement.

The memo also suggests a flow of information from the negotiating room to AIC and AIIPA, as their memo comments on a version containing changes that were not in the latest publicly available version of that time, but only first made public with the release of the political agreement on 14 December 2012.

AIC seeks no additional requirements for normal foods

I asked AIC about the involvement of AIIPA. Susanna Neuhold, Head of Foods at AIC’s national level, says she cooperated with both the main Italian consumers association Unc and the Italian gluten-free producers in AIIPA, because in Italy consumers and the dietetic food industry were together on this issue. She admits that the Italian common foods industry had a different position, but states that the AIC position was on foods specifically produced for celiacs only.

I also asked AIC about its position on gluten-free food for normal consumption. In response, Neuhold states that for food for normal consumption to be labelled “gluten free”, 20 ppm must be the only requirement. Besides that, she expects to see a separate category of foods especially rendered gluten free, for which further requirements could be set:

“As regards foods for normal consumption, we reckon (and we asked) the same provisions as now, i.e. to guarantee a maximum threshold of 20 ppm when using the claim “gluten-free” on the label of a product.

We asked more protection, instead, for “food that is especially processed, prepared or manufactured to reduce the gluten content of one or more gluten containing ingredients” (the previously so-called “dietetic foods”).”

- Susanna Neuhold, AIC, 7 December 2012.

Neuhold also refers to the second category as ‘food specifically made for celiacs’ or ex-dietetic foods, such as gluten-free bread and gluten-free pasta. For this category, AIC will now seek, at a national level, to maintain the Italian law that requires a government authorization of the production plant procedures and a mandatory notification to the Italian health ministry for every new product introduced.

While Neuhold admits that other EU countries can choose to regulate production of ‘food specifically made for celiacs’ differently, only those products that comply with the additional Italian requirements will be added to an Italian national list of ‘foods especially made for celiacs’, which makes them eligible for reimbursement in Italy’s national health service.

Recital 26 of the political agreement now calls on the Commission to think about a distinction that would make this possible. Neuhold says other European celiac societies, united in AOECS, also asked for this.

Regarding the above-mentioned AIC vote against the AOECS position of September 2012, Neuhold states that, given the current situation, AIC now supports the AOECS position and will work on a national level to maintain the guarantees on ex-dietetic foods.

In the Council of the European Union vote of 20 December 2012, Italy voted in favor of the agreement.

Final comments from AIC

After seeing this article before publication, AIC further replied that foods specially produced for celiacs, like bread, pasta and biscuits, guarantee the compliance to the gluten-free diet and therefore require additional protective requirements. This will not affect celiac consumer choice. AIC says it always pushed for maintaining the possibility for foods for normal consumption to use the claim “gluten free” and calls the suggestion that the Italian position was the result of pressure from economic interest groups “ridiculous”.

AIC further states that the Italian National Health Service reimbursement of gluten-free foods was never threatened by the use of “gluten free” on normal foods, since only the gluten-free dietetic products (i.e. food that is specifically formulated for celiacs) are reimbursed. According to AIC, the sentence in the 2011-2013 Outline of the Ministry of Health about foods for normal consumption was actually not about foods for normal consumption, but about particular categories of products, such as breaded products.

Regarding its cooperation with the dietetic foods industry, AIC states:

The AIC has worked in a transparent way in the past months, declaring publicly and openly our collaboration with AIIPA on this specific issue, and we believe that the reference to the first revision of the AIC document quoted in the article is pretextual and specious, since AIC, AIIPA and UNC have produced in recent months many joint papers.

— AIC, 21 February 2013.

Read the entire statement made by AIC in response to this blog post.

Other standpoints

De Lange expects no more surprises

MEP Esther de Lange (The Netherlands, EPP shadow rapporteur on this dossier) says she and other parliamentarians got a guarantuee from the European Commission that the existing rules of Regulation 41/2009 will be transferred straight into a new implementing act under Regulation 1169/2011. The Commission even showed them the proposed text of the implementing act, which indeed corresponded to the existing rules. Admitting that the Commission always has the right to bring new initiatives in legislation, De Lange explains that introducing changes in this subject would require the Commission to go by the European Food Safety Authority (EFSA) and the European Parliament first.

According to De Lange, Recital 26 can not be taken as a carte blanche for additional requirements. Changes like that require a more extensive procedure, for which the Commission has indicated it has no desire. She further points out that the existing rules were decided upon recently [2009] and that no problems are known that would require changes.

The agreement calls on the Commission to consider the difference between gluten free rendered foods and naturally gluten free foods. The Italian Celiacs Assocation AIC also wished for such a distinction, so it can maintain additional provisions for foods rendered gluten free at a national level.

According to De Lange, the call on the Commission is primarily meant as a request to examine if two distinct labels would be beneficial for consumers. If the European Commission would indeed like to introduce such a distinction, this could require the involvement of EFSA and national member states. De Lange further states that, as far as she knows, dietetic foods industry protection was never a motive in the negotiations on this subject.

According to De Lange, the transfer of the rules to the general food law does not affect Italy’s options to reimburse certain gluten free foods under its health insurance system, just as the existing rules did not affect this.

De Lange further points out that thanks to the transfer to the FIC Regulation, the “gluten free” labeling rules will also start to apply to non-prepacked foods.

Transfer to be completed early 2014

Barring any surprises, De Lange expects the transfer of rules to be finished between December 2013 and March 2014. Assuming the text of the political agreement is to become law by March 2013, the adoption of the delegated act would normally take 6 or 7 months and the adoption of the implementing act another 3 or 4 months.

The new agreement ensures that the existing rules of Regulation (EC) 41/2009 will stay in force until the transfer has been completed.

European Commission (Early 2012): Not by one iota

During the debates held by several committees of the European Parliament in December 2011 and January 2012, the European Commission stated very clearly that it did not intend to change the rules on “gluten free”:

“[T]he rules for celiacs as we envisage them are not going to change. The same exactly rules will be maintained with the same conditions for making the claims “gluten free” and “low gluten” and the indication that this is intended for celiacs could very well be there, so I would like to reassure everybody that the rules and the protection for celiacs is not going to change by one iota.”

– Basil Mathioudakis, Head of Unit, Nutrition, food composition and information, DG SANCO, 20 December 2011 (video, English original, clip from 11:52:30)

In a later meeting with another European Parliament committee, the Commission added that the transfer will also not affect the costs for food producers:

“I can assure you that what the Commission proposes is to take exactly the same wording of the provisions that are existing there and transfer them […]

I can assure you that nothing will change as to the protection of consumers, nothing will change as to the costs for the operators.”

– Basil Mathioudakis, Head of Unit, Nutrition, food composition and information, DG SANCO, 12 January 2012 (video, English original, clip from 12:01:35)

Of course, this was all before the Commission was asked to investigate a possible distinction between naturally gluten free foods and gluten free rendered foods.

No Council position on possibility of additional requirements

In its last year’s commentary on the European Parliaments’ first reading, the Council stated it wanted to maintain the existing rules:

“In the Council’s view, adopting, in the context of Regulation (EU) No 1169/2011 on the provision of food information to consumers, the same rules now applicable for those gluten- free foods, would ensure to coeliac people the same level of protection as foreseen in Regulation (EC) No 41/2009. It would further allow to apply the rules also to non-prepacked foods.” (underlining in original)

– Note 12132/12 from General Secretariat of the Council to Delegations, 6 July 2012 (LIMITE document made public 4 October 2012).

Again, this was before last December, when the Council approved the political agreement that calls for “at least the same level of protection” (underlining added).

Berlin dropped objections at the last moment

Until the last moment, the German delegation in COREPER (one level below the Council) opposed the agreement made on the “gluten free” issue:

“DE expressed its disapproval as it could not obtain the guarantee that the current rules on gluten will be entirely transferred under the new legal framework and because the Union list would not include the “other substances” (becoming a closed list).”

Permanent Representatives Committee (COREPER) meeting of 7 and 9 November 2012.

Germany gives two reasons for voting against the agreement. Only the first reason is related to the “gluten free” issue. The second reason is about an EU substances list, an issue not related to gluten. At a later COREPER meeting, Germany reiterates its position:

“DE expressed its disapproval to the agreement for the reasons already mentioned on 9.11.2012.”

COREPER meeting of 14, 15 and 19 November 2012.

Somewhere during the following month, however, Germany seems to have been convinced on the “gluten free” issue. As the political agreement moved up the lines from COREPER to the Council, Germany dropped its demand for a guarantee on “gluten free”. In a statement explaining their opposition to the agreement as a whole, Germany now only pointed to the substances list, a subject not related to gluten:

“Germany has always supported revision of the European legislation on dietetic foods in principle. The desired objectives of simpler and better regulation and more far-reaching harmonisation of this area of law are not, in Germany’s view, adequately achieved by the proposed Regulation.

In particular, Germany considers that the new Regulation does not take adequate account of the special level of protection required for highly vulnerable target groups. The German view is that, for reasons of preventive health protection, it is problematic to allow the unrestricted addition of various substances added, because of their nutritional or physiological effect, to foodstuffs within the scope of the Regulation.”

Statement made by the Federal Republic of Germany in the Council of the European Union, 19 December 2012

Did the Germans get the guarantee they initially wanted? Did they change their own stance? Or did they still have their doubts about the “gluten free” deal, but found them not important enough to be mentioned at Council level?

Anyone having more information about Germany’s stance in this debate, please let us know by e-mail or in the comments.

Update 5 May 2013: A follow-up article has been posted on this subject: “European Commission on gluten free: “Same level of protection””. Please leave your comments below that article.