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Katia Merten-Lentz

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Katia Merten-Lentz, partner resident in the Firm’s Brussels and Paris offices, is a leading practitioner in European food, feed, and agricultural law. Her practice also extends to Environmental Law, Biotechnologies (new breeding technologies) and Cosmetics Law.

Ms. Merten-Lentz assists clients throughout the food chain with issues ranging from marketing (food labeling, health and nutrition claims, organic labels etc.) to innovation (nanomaterials, genetically modified organisms, novel foods). She also helps clients in the food and feed area obtaining European authorization for new additives, enzymes and novel foods. Read More

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This article was published at Foodnavigator.com.

 

Edible insects are covered by the EU’s novel food regulation – but none have yet made it to the list of authorised novel foods. Legal experts from Keller and Heckman Katia Merten-Lentz and Caroline Commandeur weigh in on the the legal status of edible insects in Europe.

The importance of proteins in daily diet is now widely recognised across the world. At the same time, traditional animal sources of proteins like meat, containing all the nine essential amino acids necessary for the human diet, are becoming increasingly controversial, especially as a consequence of their big environmental footprint.

In this context, insect consumption could be an answer. Insects are complete proteins, comprising of all nine amino acids. They are also much more environmentally friendly than traditional meat production.

However, the marketing of edible insects within EU remained a sensitive issue for a long time. The legal gap on their status was only filled in 2015, with the adoption and update of the Novel Food Regulation, applicable since 2018.

 

Legal gap on insects’ status

In 1997, when the first Novel Food Regulation (EC) No 258/97 was adopted, it defined as ‘novel’ any food or food ingredient which had not been used for human consumption to a significant degree before 15 May 1997 and which fell under one of the categories listed by the regulation, including “food ingredients isolated from animals”.

However, it was silent regarding whole insects and ingredients from whole insects – such as whole insects flour, leading to diverging national interpretations on the legal status of these foods and ingredients.

For instance, the UK Food Standard Agency considered whole insects and their parts as not covered by Novel Food Regulation, while France, Spain and Sweden systematically considered insects, whichever their shape, as novel food requiring a pre-market authorization. The Belgium authorities adopted a tolerance policy in relation to ten insect species, and in Germany, no position was taken at federal level, leading to differentiated approaches among the different German ‘Länder’.

To fix and harmonize the legal status of edible insects across EU, the expanded definition of novel food since 2015 explicitly includes “food consisting of, isolated from or produced from animals or their parts” in the categories of food that may constitute a novel food. To dispel any doubts, recital 8 of the new novel food Regulation even states that “those categories should cover whole insects and their parts”.

Insects now clearly fall into the scope of the Novel Food Regulation, and for this reason must be specifically authorized and included in the Union list of authorized novel food, to be placed on the European market.

However, such list, established by Regulation (EU) No 2017/2470, does not contain any insects or food derived from such animals yet.

 

Transitional measures

The patchwork of legislation in Member States necessitated the introduction of transition arrangement to cover foods that had been legally sold prior to 2018.

Article 35(2) of Regulation (EU) No 2018/2283 details these transitional measures with respect to insects lawfully placed on the market before 1st January 2018 in Member States who previously permitted it such as Netherlands, UK, Finland or Denmark.

Such products may continue to be marketed until an Novel food authorization is granted in accordance with the new novel food rules. In other words, food business operators have to submit to the Commission either an application for authorization of a novel food (in accordance with articles 10 to 13 of the Novel Food Regulation), or a notification of a traditional food from a third country (as set out in articles 14 to 20 of the Novel Food Regulation).

There is a strict deadline for submitting their dossier: before 1 January 2019.

 

Strategic choice for applicants: notification and authorization procedure

Whether to seek approval via the authorization or notification procedure is an important strategic decision for food makers.

As insects are commonly part of the daily diet in other parts of the world and derived from primary production, they could theoretically fit with the definition of traditional foods from third country. If a food business operator is able to demonstrate a history of safe use for at least twenty-five years in a third country, he can opt for a simplified procedure of notification, instead of following the whole procedure of authorization.

However, this notification procedure does not prevent Member States and/or European Food Safety Authorities from making some duly reasoned safety objections to the placing on the market of the traditional food.

Taking into account recent EFSA’s publications on risk profile related to consumption of insects as food (2015) and for the house cricket (2018), which both highlighted the lack of data related to possible hazards when insects are used as food, this procedure is probably not suited for fast-track placing on the market of edible insects.

Moreover, the choice for this fast-track procedure would also prevent the applicant from requesting data protection, a possibility the standard authorization procedure normally offers.

To date, five novel foods applications regarding insects have been submitted to the European Commission: two species of crickets (acheta domesticus and gryllodes sigillatus), two types of mealworm (tenebrio molitor) and mealworm larvae products (alphitobius diaperinus).

None of EFSA’s scientific opinions on their safety have been published yet. However, the first two draft scientific opinions were discussed in early October 2018: it was considered that additional information from the applicant was needed to proceed with the scientific assessment of applications regarding dried mealworm.

In this context, even if the legal gap on their status was filled, insects will not be part of our European diet in the coming months.

This article is written by Katia Merten-Lentz and published at Food Manufacture

In a paper dated 6 September 2017, the European Commission (EC) stated that if IP rights – such as those for Protected Designation of Origin (PDO), Protected Geographical Indication (PGI), and Traditional Specialities Guaranteed (TSG) – were granted before Brexit, they should be enforceable in the EU and the UK afterwards. But to ensure recognition of these rights, the UK must put this legislation in place before the withdrawal date, and there is currently no UK legislation on PDO, PGI and TSG labels.

An official agreement regarding such marks has still to be reached. We also don’t know if applications made during the March 2019 and December 2020 transition will be protected.

The EC paper states that where applications have been submitted to an EU body before the withdrawal date and if the administrative procedure is ongoing on that date, applicants should be entitled to keep the benefit of any priority date in respect of such applications.

Marks from third countries can get EU protection, subject to agreement. If negotiations on this succeed and equivalent UK legislation is set up, there will be no need to reapply from scratch.

Companies should have  applied under current EU law before Brexit to have the best chance of securing such labels.

  • The Government has pledged to set up UK GI schemes and logos, compliant with World Trade Organisation rules, after Brexit. The 86 current EU GI holders would be included.

Cet article a été publié sur Les Marchés, le Média de l’alimentaire.

 

Le 13 septembre 2018, en session plénière, les députés européens ont voté massivement en faveur d’une résolution non législative appelant les États membres, la Commission et les associations de consommateurs, à lutter davantage contre le phénomène de « qualité différenciée » des denrées alimentaires. Décryptage.

Le règlement concernant l’information des consommateurs sur les denrées alimentaires, dit règlement Inco, exige que les informations données aux consommateurs soient loyales, et ne les induisent pas en erreur quant aux caractéristiques des produits, notamment sur leur nature, identité, qualité, composition ou mode de fabrication. Il est toutefois possible pour les producteurs de vendre des produits adaptés aux préférences locales et aux goûts du pays de destination, à condition de ne pas tromper le consommateur. Ainsi, si un opérateur vend un produit dans toute l’Union européenne (UE) avec une composition qui varie d’un pays à l’autre, il ne doit pas l’étiqueter de façon identique. Or, des enquêtes menées dans plusieurs États membres de l’UE, principalement en Europe de l’Est, ont démontré que des produits vendus sous la même marque et dans des emballages apparemment identiques différaient, par leur composition et leurs ingrédients, parfois de manière significative.

Aussi, afin d’aider les autorités nationales à déterminer si une entreprise enfreint le droit de l’UE en vendant des produits de qualité différenciée, la Commission a publié en septembre 2017 une communication expliquant comment appliquer le règlement Inco, ainsi que la directive sur les pratiques commerciales déloyales, en préconisant une approche au cas par cas, qui prenne en compte le marketing, l’écart de composition et le degré d’information des consommateurs quant à cette différence. Mais ces lignes directrices seraient, aux dires des parlementaires, insuffisantes pour lutter contre ce phénomène.

New deal pour les consommateurs

Au printemps 2018, la Commission s’est à nouveau saisie du problème. En premier lieu, dans le cadre d’une initiative intitulée « new deal pour les consommateurs », elle a annoncé, en mars, qu’elle lançait un centre de connaissances pour améliorer la qualité des denrées alimentaires et renforcer la lutte contre la fraude alimentaire, qui sera géré par le Centre commun de recherche (CCR).

Puis, en avril, elle a publié une proposition d’amendements de plusieurs directives relatives à la protection du consommateur, notamment celle sur les pratiques commerciales déloyales, introduisant la notion de « double niveau de qualité », comme une pratique commerciale trompeuse.Elle suggère également que les États membres fixent, dans leur droit national, des amendes correspondant à au moins 4 % du chiffre d’affaires annuel du professionnel reconnu coupable d’infractions de grande ampleur qui portent préjudice aux consommateurs dans plusieurs États membres.

Enfin, en juin, le CCR a indiqué avoir mis au point une méthodologie commune permettant aux autorités nationales chargées de la protection des consommateurs de réaliser des tests visant à comparer la composition et les caractéristiques des produits alimentaires vendus dans l’UE sous un emballage similaire.

L’intervention du Parlement européen

Mais les parlementaires européens incitent la Commission à améliorer également la coopération transfrontière et le partage des informations entre les États et les associations de consommateurs, afin d’identifier les produits ne respectant pas la législation, ainsi qu’à mettre en place un cadre juridique permettant l’indemnisation des consommateurs par les producteurs, en cas de violation de leurs droits.

C’est pourquoi, ils ont adopté le rapport (précité) déjà validé en juin, de la Commission du marché intérieur et de la protection des consommateurs (Imco).Les députés, à cette occasion, appellent les fabricants à apposer un logo sur l’emballage de leurs produits d’une même marque, informant le consommateur que le contenu et la qualité sont les mêmes dans tous les États membres.

Il revient maintenant à la Commission européenne d’étudier ce rapport et de prendre éventuellement en compte certaines de ses préconisations. Le débat se poursuivra parallèlement au sein de la commission Imco, chargée de la proposition législative de la Commission modifiant la directive sur les pratiques commerciales déloyales.

Veganism has soared in Europe over the past years but there is no legal definition either for “vegetarian” or “vegan” in EU law. Katia Merten-Lentz of international law firm, Keller & Heckman, looks at how regulatory clarity could come about.

03 october 2018

This article is written by Katia Merten-Lentz and published at EU Food Law

While there are no precise statistics on the number of vegans in Europe, it is estimated that 3.5 million British people and over 1.3 million Germans are now identifying themselves as such, as well as 5% of the French.

However, this increasing visibility of veganism in society contrasts with the slow pace of changes regarding the legal framework with respect to the labelling of vegan food.

Vegans try to avoid as much as possible all forms of exploitation of animals for food, clothing, or any other purpose.

In terms of food habits, it denotes the practice of staying clear from all products derived wholly or partly from animals. However, there is no legal definition of ‘vegetarian’ or ‘vegan’ in EU law, and as a result, there is no specific harmonised European legal framework for labelling vegan and vegetarian food either.

The Commission is supposed to adopt implementing acts on voluntary information related to the suitability of a food for vegetarians or vegans, but it recently stated that it will only start working on this issue in 2019. Setting up these definitions is sorely needed to ensure the validity of vegan claims and to provide for a better information of the consumer.

 

Absence of strict criteria regarding vegan food

As there is no specific dispositions on vegan or vegetarian food in EU law, the first issue regarding these labels is to determine which regulations apply to them.

Health claims and nutrition claims  are covered by an EU regulation. However, the indication ‘suitable for vegans’ on a product cannot fall within this regulation, since nutrition claims suggest or imply that a food has specific beneficial nutritional properties, which is not necessarily the case of vegan food.

This means that the general framework applies to vegan food, more specifically the provisions of Regulation 1169/2011 (also known as the “the FIC Regulation”) , which states that food information provided to the consumers must allow them to “make informed choices and to make safe use of food, with particular regard to health, economic, environmental, social and ethical considerations.” The main goal of this regulation is ensuring that the consumer is not mislead by the information provided on the labelling of products.

The FIC Regulation lays down the possibility of adding voluntary food information on the packaging , which means that operators can indicate on the product that it is vegan, if they respect some conditions.

The information must not be ambiguous nor confusing for the consumer, and must also be fair, particularly as to the composition and method of production . That is why the absence of a definition is problematic regarding vegan food. Due to the lack of harmonisation, private labels have multiplied, and they do not always set up the same criteria for a product to be labelled as “vegan”. Indeed, sometimes products are marketed as vegan or vegetarian while they used processing aids or additives obtained through processes involving animal products (For example xanthan gum, an additive, can be produced using a fermentation process involving whey, a dairy ingredient).

Moreover, some operators also indicate ‘vegan’ on the package while not even referring to a particular private label, therefore it is difficult for the consumer to know if the product was really obtained without any animal products.

On the other hand, the names of vegetarian and vegan food often refer to animal products – like “vegan milk” or “tofu steak” – while evidently not containing any milk or meat. This can be confusing for the consumers, and operators of the meat and dairy sectors have begun to complain about the use of these denominations.

Denominations of vegan products: the war regarding the name ‘steak’

In its judgement ‘TofuTown’ of 14 June 2017, the Court of Justice of the European Union considered that vegetal products cannot, in principle, be marketed under names such as ‘milk’, ‘cream ‘, ‘butter’, ‘cheese’, ‘yoghurt’, as EU law reserves these designations for animal products.

The Court expressly said that this helps protecting the consumers against any confusion as to the composition. It is thus now impossible to market a vegan product under the name ‘vegan cheese’ or ‘soya milk’.

The issue has never been raised before the Court regarding meat, but it has been brought up by members of the European Parliament. In May 2018, a MEP has asked the Commission what it was planning to do to prevent operators to use terms such as ‘meat’, ‘hamburger’ or ‘steak’ for referring to products that contain little or no meat.

The Commission replied that according to the FIC Regulation, food information shall not be misleading as to the nature and composition of the food, and that since term ‘meat’ was already defined in EU law , it could thus not be used for a product that does not contain any meat. However, the Commission did not say anything about fighting the use of other denominations.

Indeed, words like ‘nuggets’, ‘burger’, ‘steak’ or ‘sausage ’are not defined in EU law , so in principle they can be used for vegetal products as long as they do not mislead consumers about their nature and mode of production.

The Commission will not be able to stay silent on this issue for much longer because in an even more recent parliamentary question , Mara Bizzotto (ENF) asked if the Commission was considering granting special protection for sales denominations of meat-based products against the “growing unfair competition from vegetarian and vegan products which imitate their appearance and labelling”.

Ms Bizzotto stressed that more and more food products for vegetarians and vegans are marketed in such a way as to suggest that they are ‘substitutes’ for meat-based products, even though their ingredients and nutritional contents are completely different.

Therefore, it seems that the future discussions on the matter will have to determine if there is a real possibility of confusion in the mind of a consumers between a ‘soya steak’ and a normal beef steak.

The Commission has yet to reply to this latest parliamentary question, and its answer is becoming more and more necessary in order to harmonise this issue.

Indeed, Member States are starting to take the matter into their own hands, which could hinder the free movement of vegan products.

France recently passed an amendment to its agriculture bill that prohibits any product that is largely based on non-animal ingredients from being labelled like a traditional animal product. While the reform is not adopted yet, it is thus probable that names such as ‘vegetable steak’ or ‘soy sausage’ could be banned in French territory soon, making the need of a consensus at the EU level an even more pressing issue.

Valorisation des déchets et prevention du gaspillage alimentaire

Cet article a été publié sur Food Process.

 

Déchet ou aliment ? Le développement récent de techniques orientées vers l’optimisation des ressources et le respect de l’environnement dans la chaîne alimentaire, soulève de nouvelles questions juridiques au regard de la réglementation applicable aux produits. Trois directives relatives aux déchets, ainsi qu’à leurs emballages modifiant les textes précédemment en vigueur, ont été définitivement adoptées par le Conseil le 22 mai 2018 et sont entrées en vigueur début juillet. Focus sur l’une d’entre elles, la directive déchet modifiée, et ses dispositions sur le gaspillage alimentaire.

 

Definition du gaspillage alimentaire

Le gaspillage alimentaire, qui se produit à toutes les étapes de la chaîne alimentaire, de la production agricole à la consommation finale, atteint des proportions importantes dans l’Union européenne avec en moyenne 173 kg de denrées alimentaires perdues ou gaspillées par personne par an. La Belgique est le deuxième Etat européen, après les Pays-Bas, en termes de gaspillage alimentaire, avec 345 kg en moyenne par personne par an.

Le 2 décembre 2015, dans le cadre du paquet «économie circulaire », la Commission européenne a soumis un projet de révision relatif aux déchets. Un accord politique a finalement été trouvé, à l’automne dernier, ouvrant la voie à l’adoption des nouveaux textes et réaffirmant la volonté des institutions européennes de renforcer les objectifs européens de réduction et de meilleure gestion des déchets.

La nouvelle « directive déchet » définit explicitement le gaspillage alimentaire comme « toutes les denrées alimentaires au sens de l’article 2 du règlement (CE) nº 178/2002 qui sont devenues des déchets». Elle fixe également l’objectif de réduire ce gaspillage de 30 % d’ici à2025 et de 50 % d’ici à 2030. Ces objectifs s’inscrivent exactement dans la ligne politique déjà suivie par la Wallonie. En effet, en 2015, le Gouvernement wallon a adopté le Plan wallon de lutte contre les pertes et gaspillages alimentaires. Baptisé Plan «REGAL», il comporte 17 actions visant à réduire de 30% le gaspillage à tous les échelons de la chaîne alimentaire à l’horizon 2025.

 

Les mesures d’indication aux dons

Pour atteindre cet objectif, la directive prévoit que les États membres devront mettre en place des mesures d’incitation afin de recueillir les produits alimentaires invendus à toutes les étapes de la chaîne d’approvisionnement alimentaire et les redistribuer dans des conditions sûres, notamment à des organisations caritatives. Il s’agit de généraliser, à l’échelle européenne, l’adoption de législations dites du « bon Samaritain », déjà mises en place dans certains États membres.

Il convient de rappeler que la Belgique a  pris des mesures concrètes pour lutter contre le gaspillage des denrées alimentaires au cours de ces dernières années. Un décret du 13 mars 2014 pris par le Parlement de Wallonie prévoit notamment une obligation pour les exploitants de grande surface de distribution de plus de 2.500 m² de proposer les invendus alimentaires à au moins une association active dans le secteur de l’aide alimentaire. Ils doivent, en effet, respecter cette obligation s’ils souhaitent que leur permis d’environnement soit renouvelé. Au niveau local, les communes peuvent même décider d’imposer cette obligation à des supermarchés de taille plus réduite.

La nouvelle directive indique que les mesures d’incitation en faveur du don des denrées alimentaires, peuvent être notamment fiscales, mais elle ne fixe aucune obligation à cet égard pour les Etats membres. Ceux-ci n’ont cependant pas attendu cette réforme pour diminuer, voire supprimer la TVA s’appliquant aux dons de denrées alimentaires. En Belgique par exemple, la suppression de la TVA s’est opérée en deux étapes, avec d’abord le 31 juillet 2013 son abandon pour les supermarchés s’ils faisaient don de denrées alimentaires invendables, mais seulement aux banques alimentaires nationales. Puis, en mai 2015 l’exonération avait été généralisée à toutes les organisations caritatives, facilitant ainsi le don de denrées alimentaires par les petits commerces et épiceries de quartier.

 

La gestion des biodéchets et leur réutilisation

Le nouveau texte généralise la collecte séparée des biodéchets, en l’étendant aux déchets alimentaires ou de cuisine des ménages, des restaurants, des magasins de vente au détail, ainsi qu’aux déchets comparables provenant des usines de transformation de denrées alimentaires.

Les nouvelles dispositions permettent donc une meilleure définition du champ d’application de la législation sur les déchets au regard de la réglementation alimentaire, tout en appréhendant le problème du gaspillage alimentaire. Le texte pourrait donc présenter des opportunités intéressantes pour les industriels en matière de gestion des déchets.

Cet article a été publié sur Agra Alimentation, le média des enjeux de stratégiques et financiers de l’agroalimentaire.

 

CJUE > Les nouvelles techniques de sélection végétale engendrent-elles des OGM au sens du droit européen? Saisie de cette question par le Conseil d’État français en 2015, la Cour de justice de l’Union européenne (CJUE) vient de répondre par la positive, en décidant, le 25 juillet 2018, que les organismes obtenus au moyen de techniques/méthodes de mutagenèse, constituent des organismes génétiquement modifiés au sens de la directive OGM.

Depuis 2001, en application de la directive dite OGM, un organisme génétiquement modifié est défini comme « un organisme, à l’exception des êtres humains, dont le matériel génétique a été modifié d’une manière qui ne s’effectue pas naturellement par multiplication et/ou par recombinaison naturelle ».

À ce titre, il doit faire l’objet d’une autorisation préalable de mise sur le marché. De plus, l’utilisation d’une variété végétale génétiquement modifiée n’est possible que si toutes les mesures appropriées ont été prises pour éviter les risques pour la santé humaine et l’environnement…

Cependant, jusqu’à présent, les organismes issus de certaines techniques, telles que la mutagénèse, bénéficient d’une exemption et ne sont pas soumises aux obligations (contraignantes) de la directive OGM. En effet, contrairement à la transgénèse, la mutagénèse ne nécessite pas l’insertion d’ADN étranger dans un organisme vivant et, par conséquent, l’organisme obtenu n’est pas considéré comme un OGM.

Mais cette exemption ne concerne que des méthodes de mutagénèse dites conventionnelles ou aléatoires, appliquées in vivo, afin de créer des variétés tolérantes aux herbicides (VrTH) et utilisées depuis des décennies, sans engendrer de risques identifiés pour l’environnement, ou la santé.

Or, de nouvelles techniques/méthodes sont apparues ces dernières années. Certaines d’entre elles sont aujourd’hui appliquées in vitro ou de manière ciblée, afin de provoquer une mutation précise dans un gène, et leur distinction d’avec un OGM semble de plus en plus ténue.

 

Une distinction entre les méthodes « traditionnelles » et les méthodes « nouvelles »

Interrogée en premier lieu sur l’application de la directive OGM à ces nouvelles techniques, la Cour de Justice a, tout d’abord, considéré que, dans la mesure où les techniques de mutagenèse modifient le matériel génétique d’un organisme d’une manière qui ne s’effectue pas naturellement, les organismes obtenus par mutagenèse sont des OGM.

Néanmoins, en ce qui concerne l’exemption prévue par la directive, la cour opère une distinction entre les techniques de mutagénèse dites « traditionnelles » et les nouvelles techniques.

Contrairement aux techniques de mutagénèse qui ont été traditionnellement utilisées pour diverses applications et dont la sécurité est avérée depuis longtemps, les nouvelles techniques de mutagénèse « dirigée » permettent d’obtenir les mêmes effets que la transgénèse et de produire des variétés génétiquement modifiées « à un rythme et des proportions sans commune mesure avec ceux résultant de l’application de méthodes traditionnelles de mutagénèse aléatoire ».

Leur dissémination pourrait donc produire des effets irréversibles sur l’environnement, ce qui contreviendrait aux principes énoncés par la directive, à savoir le principe de précaution et de protection de la santé humaine et de l’environnement.

Aussi, aux termes d’une lecture rigoureuse du texte de la directive et de ses objectifs, la Cour a décidé que les organismes issus de nouvelles techniques de mutagénèse, ne peuvent pas bénéficier de l’exemption prévue par la directive et doivent donc être soumis aux procédures d’autorisation préalable.

 

La réglementation des organismes obtenus par mutagénèse traditionnelle

La Cour n’a pas remis en cause l’exemption dont bénéficient les organismes issus de mutagénèse traditionnelle Et a même ajouté que les variétés végétales obtenues à partir de ces organismes pourront être utilisées sans que des mesures spécifiques n’aient à être prises.

Mais les États membres restent libres d’adopter des législations nationales spécifiques afin de les soumettre aux obligations prévues par la directive OGM, ou à d’autres obligations.

Du droit à l’innovation

Bien qu’elle éclaire les industriels sur le statut juridique des organismes issus de nouvelles techniques de mutagénèse, cette décision contredit à la fois les conclusions de l’avocat général Bobek et l’avis du Haut Conseil français des biotechnologies de novembre 2017, et peut donc surprendre.

De surcroît, le cadre réglementaire auquel il les soumet, est très contraignant et limite la possibilité de prendre en compte les perspectives réelles de développement des biotechnologies dans le secteur semencier.

Cela étant, cette décision devrait permettre à la Commission européenne – qui n’a pas de pouvoir d’interprétation de la législation – d’avancer enfin sur l’évaluation de ces nouvelles techniques (attendue pour fin 2018) et éventuellement, l’élaboration d’une réglementation spécifique.

Cet article a été publié sur Les Marchés, le Média de l’alimentaire.

 

Saisi d’une demande d’annulation du décret français rendant obligatoire l’étiquetage de l’origine de la viande et du lait dans les produits transformés, le Conseil d’État a interrogé la CJUE, le 27 juin dernier, sur la possibilité pour les États membres de réglementer cette question à l’échelle nationale.

En Europe, le règlement 1169/2011, dit Inco, harmonise les règles applicables à l’étiquetage des denrées alimentaires et établit un principe de loyauté des informations transmises au consommateur final. À ce titre, l’indication de l’origine n’est obligatoire que lorsque son omission serait susceptible d’induire en erreur les consommateurs. C’est le cas, en particulier, si les informations jointes à la denrée, ou l’étiquette dans son ensemble, peuvent laisser penser que la denrée a un pays d’origine ou un lieu de provenance différent, ou si l’origine indiquée n’est pas celle de son ingrédient primaire.

La Commission européenne devait, au plus tard le 13 décembre 2014, présenter un rapport sur l’étiquetage de l’origine de certaines denrées, telles que la viande, le lait et les produits laitiers. Or, dans l’attente de telles précisions, les hypothèses où cette mention devient obligatoire se sont largement multipliées à l’échelle nationale.

Marge de manœuvre faible des États membres

Entre harmonisation et justification, la marge de manœuvre des États membres est faible. En principe, les États membres ne peuvent ni adopter ni conserver de mesures nationales, sur des questions harmonisées par le règlement Inco. Ils peuvent toutefois introduire des mesures sur l’indication obligatoire de l’origine de certaines denrées pour assurer la protection du consommateur, sous réserve de respecter deux conditions : un lien avéré entre certaines propriétés de la denrée et son origine, ou sa provenance, et le fait que la majorité des consommateurs attache une importance significative à cette information.

En France, le décret no 2016/1137 du 19 août 2016 impose ainsi l’indication de l’origine du lait et des viandes utilisés en tant qu’ingrédient dans les denrées préemballées. Les opérateurs français sont, en principe, tenus d’indiquer le pays de collecte, de conditionnement et de transformation du lait. Notifié à la Commission, ce décret est applicable depuis le 1er janvier 2017… jusqu’au 31 décembre 2018, date à laquelle la Commission devrait analyser son impact sur le consommateur.

Demande d’annulation par Lactalis

Le Conseil d’État français a cependant été saisi, par la société Lactalis, d’une demande d’annulation de ce texte. Selon elle, la mention de l’origine est harmonisée par le règlement Inco, ce qui exclut la possibilité pour la France de réglementer la question. Elle soutient aussi que – quand bien même le règlement Inco laisserait la possibilité à un État de réglementer cette question – l’existence d’un lien avéré entre certaines propriétés de la denrée et son origine ou sa provenance n’est pas démontrée. Mais le Conseil d’État ne pouvant pas interpréter les dispositions européennes, il s’est tourné vers la CJUE, pour l’interroger sur la portée des deux critères prévus par le règlement Inco pour l’adoption d’une mesure nationale visant à protéger le consommateur.

Bien que la CJUE ne soit pas en mesure de répondre à cette question préjudicielle avant la fin de l’expérimentation française (fin 2018) compte tenu des délais de procédure, sa saisine reste très pertinente au regard de la légalité de plusieurs autres mesures nationales en matière d’étiquetage de l’origine des denrées en Europe.Cette question est d’autant plus délicate, qu’au-delà de la stricte interprétation des dispositions du règlement Inco, elle met surtout en balance la protection de l’agriculture nationale et la libre circulation des denrées.

This article originally appeared in WorldFoodRegulationReview.

The 50th session of the Codex Alimentarius Committee on Food Additives (CCFA50) has completed its full agenda and found consensus on many new food additives provisions, which has reduced significantly the backlog from past years on miscellaneous food additives, with a good perspective to complete this task at its next session(almost two years ahead of schedule). And, against all odds, CCFA50 agreed for the first time since 2012 to work on a handful number of colour additive provisions in a limited number of confectionery categories for possible adoption as of the 2019 CCFA51 session (i.e. part of the GSFA mandate) as a test case for all the colour pending provisions. The Committee also modernised some of its internal procedures – and relations with JECFA – to speed up future work. CCFA50 seems to have slightly changed its mind about enzymes since last year and agreed to give a higher consideration to enzymes in the future, especially for their review by JECFA. The Committee also endorsed internal guidelines with other Codex Committees on the crucially important alignment between food additives provisions in the GSFA1 and those approved in Commodity Standards. As a good example, CCFA50 has completed the alignment work for fish and fishery products standards fully, and in the future, it will also rely more on active Codex commodity committees to perform such an alignment task. Last but not the least – and totally unexpectedly –CCFA50 agreed to start again the discussion on Note 161 related to some provisions on intense sweeteners, where left unanswered three years ago.

Mr. Christophe Leprêtre2
Mrs. Katia Merten-Lentz3

The 50th session of the Codex Alimentarius Committee on Food Additives was held in Xiamen (China) from 26 to 30 March 2018, preceded by a two-day pre-session working group in person (PWG) to advance recommendations to the CCFA50plenaryontheGSFA.CCFA50alsoheld3 in-session working groups to advance recommendations to CCFA50 plenary on Alignment, the INS and class names of food additives, and priorities assigned to JECFA for safety evaluation, specification reviews among other tasks.

“CCFA 2.0”: Yes indeed, but practical implementation should be tested

The discussion held on the last afternoon of the plenary was deliberately oriented to consider those recommendations only as a common pathway for future ways of working, rather than to make clear-cut choices between the various suggested different options under each recommendation.

Therefore, all the expected debates fell quite short and many written comments submitted were not raised in plenary, except for the key countries (China, EU, Australia, Canada, USA, New Zealand) and only from a handful number of observer organisations.

  • Note 161 – No battle, mainly due to an absence of willingness to fight, this time…

The suspense was carefully kept until the very end of the plenary of CCFA50, as in any very good movie. And bang! The CCFA 50 did not discuss the Note 161 issue. Like a couple of magicians pulling out a peaceful white rabbit from a hat on stage, the USA and the EU4 suggested that the Committee shall resume its discussions exactly where it left them three years ago, in reutilizing the report of an old electronic working group, led at that time by the UK on three intense sweeteners. For sure, such a concerted solution must have been subject to intense informal discussions, day and night, during the whole CCFA50.

Therefore, CCFA50 tasked an electronic working group (EWG) to review the 2015 EWG recommendations which classified selected sweeteners provisions in six batches; each of them offering a possible dedicated solution to replace the Note 161 with other existing notes (i.e. with no added sugars; energy-reduced; or a combination) or new notes. It should be mentioned that the past work did not cover all intense sweeteners provisions, but only those for aspartame, acesulfame K and the salt of aspartame-acesulfame, both already adopted (i.e. included in the published GSFA, alias CXS 192) and draft provisions (i.e. provisions in the step process)5.

Smiling moment: when the CCFA50 Chairman asks, who would like to chair this new EWG, then both the USA and the EU were prompt to offer their support – but both as co-chairs – as none seemed to be truly prepared to take the lead on this “hot potato” issue. Alike the (lack of) outcome of the CCFA47 negotiation in 2015, the situation looks like “even” – starting with this chairmanship issue. As pointed out by Germany though, a new spirit seems to have emerged within the CCFA delegations, so maybe this time solutions matching all the contradicting and polarized positions (including within the various industry sectors) may be found… At least, one reassurance: Note 161 issue is like a CCFA type of phoenix… It resuscitates and rises from the ashes. It is the second time in the past 10 years it does so. Future may tell, “what about this time?”

  • Key factors to speed up the review process by the CCFA
  • Reducing the time-lapse between a draft entry in GSFA and final adoption

CCFA50 agreed that once it would agree to enter new (or revised) draft provisions for a food additive in the GSFA, such provisions would be immediately circulated to the CCFA community for comments and consideration at the immediate next session. At last! Indeed, this very simple solution is intended to alleviate the current uncertainty between entry into the GSFA of a draft provision and consideration by the CCFA for possible adoption.

Some provisions reviewed by CCFA50 this year have been waiting for 20 years before being considered. The new process flow may help to ensure more foreseeability, especially for new substances which were recently reviewed by JECFA. However, CCFA50 is somewhat conditioning the implementation of that decision to until after next year’s session. Who knows what may happen then…

  • Decisions to help with the work on Alignment (between GSFA and Food Standards)

CCFA50 took several decisions and anticipated a little bit ahead of the new working procedure. The new working procedure would involve organisations representing technical expertise in a defined food sector. As such, and in line with another CCFA50 decision to ask the International Dairy Federation (IDF) to prepare the future background alignment work on alignment of food additive provisions for all ripened cheese standards, CCFA50 agreed to use further Codex observers for preparatory work, nominated Japan as co-chair of the regular inter-session EWG on alignment (chaired by Australia) and agreed to enhance the partnership with and the delegation of the preparatory alignment work to other active Commodity Committees (see more details on Alignment below). The European Union delegation indicated that Codex observer’s preparatory work will need to be scrutinized very carefully by Codex members (all country and EC representatives) to avoid any mismatch.

  • Marginal decisions on the INS but important precisions a new policy rule

CCFA50 agreed to amend the general section of the INS (i.e. CAC/GL 36, now CXG 36) to add some precisions that the INS list may include names of substances not evaluated by JECFA (reminder) or that are not included in the GSFA (this is the newly added text). As a consequential change and other recommendations adopted by CCFA50, the yearly Codex Circular Letter requesting comments on the INS is amended. It will now specify that any proposal for deletion of INS entries cannot be submitted if there are existing provisions (adopted or in the Step Process) for the additive in the GSFA with the understanding that the CCFA must first take a formal decision to remove those provisions from the GSFA prior to the submission of proposals to delete a corresponding INS entry.

  • Prioritize new work for JECFA and other aspects

CCFA50 recognized almost unanimously that the primary key factor to review a substance (a food additive, including flavouring, and processing aids such as enzymes, all included in the Codex definition of “food additive”) was when it raises a food safety concern. Potential trade issues linked to “imperfect” specifications were also noted but the question may diverge about what “imperfect” is, as countries and industry groups may not have the same interpretation – nor the same needs – about that. But the discussion went in sequence: classical food additives (for inclusion in GSFA) and enzymes and flavourings (only covered by Codex Guidelines and where Codex only approved the specifications).

The Committee endorsed the recommendations included in the discussion paper but left open to give it a second thought soon. Therefore, the Committee is now giving the highest priority to re-evaluation of existing food additives should new safety concern(s) may arise. Then, it may consider on equal grounds the safety evaluation of new substances (including establishment of specifications) and the optimization of existing specifications.

Regarding food additives other than enzymes and flavourings, one observer reminded the Committee that the Committee already worked intensively – eight years ago – at a scoring screening system developed by Canada, with the help of multiple successive electronic working groups. This is based on a screening tool that the prioritization of colours for re-evaluation was established. It was pointed out that such a list was still the one used by JECFA to carry on with the re-evaluation program of such prioritized colours. It should be noted that many criteria were included in the screening score tool and that the date of the last JECFA evaluation was viewed as an important criterion, but not the only one to be considered and weighed. The tool was never further tested for other groups of food additives than colours.

Regarding the type of questions to be added to the Codex circular letter requesting comments for new JECFA work, the Committee tasked the JECFA secretariat and Codex secretariat to work on what improvement could be made for consideration at the next in-session WG on JECF A priorities (at the 2019 CCFA51). This work would certainly echo the decision already made by the Canada Chair during this session WG on JECFA priorities to populate more information about the various requests so that the information is not lost. It also echoes the JECFA/WHO statement about the additional requirements for naturally sources substances (e.g. plant extracts) in terms of chemical characterization and toxicological profiles. The two suggested options were retained as one covering flavourings and another one enzymes.

  • Processing aids: no clear decision on a dedicated standard on all types of processing aids

CCFA50 recognised and stated again that the current database on processing aids – which is maintained up-to-date by the Chinese government with technical support from New Zealand expert – is not a Codex text nor a recognition of any type of the list of substances but rather a simple inventory. CCFA50 did not agree to develop a dedicated Codex standard on processing aids, despite the heavy support by New Zealand and Australia for the idea.

At minima, CCFA50 conceded that the current Codex Guidelines on Substances used as Processing Aids (CAC/GL75, i.e. CXG 75) may be reviewed/amended, as a future priority and not to be completed at this point in time. At the same time, many enzymes have been added to the priority list for JECFA safety evaluation and establishment of specifications (see further below). Last year, CCFA49 concluded that priorities assigned to JECFA needed to go first and foremost to food additives. Well, well, well…

Regarding how the Committee would decide upon the order by which priorities are set, the recommendation was discarded. While the EU called upon a more inclusive and transparent process for qualitative evaluation of the new work, Australia encouraged the Committee not to lose the core principles underlined by the priority order settings and urged the committee to develop a mechanism to address prioritization. But the Committee simply decided not to. This means that the current status quo may prevail, with marginal other changes made. Therefore, there is no real innovative approach on the go. And it is still not clear how all the other decisions made on the other recommendations will work out together towards the objective of the “One CCFA approach”.

GSFA pending provisions: landmark progresses made by CCFA, despite The Voice’s extinction and controversial debates on several key provisions on “other fluid milks (plain)” and “water-based flavoured drinks” (i.e. soft drinks)

A two-day CCFA50 pre-session working group (PWG) went through all pending GSFA provisions on its agenda (see WFRR Vol. 27, Number 9, Feb. 2018) and reviewed new proposals for inclusion of other draft provisions at Step 2. Mostly, it suggested to CCFA50 plenary provisions for (i) adoption, (ii) revision, (iii) discontinuation and (iv) revocation. CCFA50 plenary endorsed most of them. It is a spectacular result obtained by the Chair of the PWG, Dr Paul Honigfort (USA-FDA) and a landmark performance, given a painful voice extinction which made him suffer during the full duration of the debates. That result is also the expression of a new spirit of compromise blowing throughout all delegations, except on a few issues reported below.

(i) Draft and proposed draft provisions in the GSFA regarding the second half of food categories (from fish products to prepared foods)6;
(ii) new provision for inclusion at step 2 in the GSFA or proposed revisions of already approved provisions in GSFA;
(iii) Proposed draft provisions related to fluid milk (plain); (iv) Proposed draft provisions related to the recently created new food category on other fluid milk (plain)7;
(v) Lutein esters from Tagetes erecta and octenyl succinic acid (OSA)-modified Gum Arabic proposed for inclusion in Table 3 of the GSFA (i.e. GMP use unless otherwise regulated);
(vi) Some provisions in food categories subject to standardized foods on processed fruits and vegetables and edible oils.

It is virtually impossible to report here about each individual decision taken by CCFA50 based on the 250+ pages long working document. All CCFA50 decisions about each draft provision proposed for final adoption and inclusion in the published GSFA (subject to formal approval by the next Codex alimentarius Commission (CAC41, July 2018)) are included in Appendix V-Part A of the CCFA50 report.

The one provision proposed for revocation (by a CAC41 approval decision)8 is included in Appendix VI. The quite few new draft provisions introduced in the GSFA (at Step 2 and 3) are reported in Appendix VII, and draft provisions discontinued and to be deleted from the step process (decision enacted immediately) are included in Appendix VIII.

However, it may be of interest to note that several provisions did lead to some very interesting debates. The following have been identified as the most remarkable ones.

  • Trisodium citrate in plain fluid milk

Although the pre-session working group on GSFA found compromise on permitting this food additive at GMP level in UHT milk from non-bovine species only, only as emulsifier and stabilizer, Brazil and New Zealand raised the need to add sterilized milk and maybe not add the restriction to other species then bovine (whereas the EU made clear that it is technologically justified in e.g. goat milk and not in bovine milk). Thus, the provision will be discussed again next year.

  • Emulsifiers, Thickeners, and Stabilizers in other types of plain fluid milks

This topic has led to harsh discussions both during the pre-session working group and the CCFA50 plenary. Members were split on the question whether the use of emulsifiers and stabilisers may be justified for use (i) in this full food category (i.e. all the fluids milks other than those covered by food category plain (unflavoured) fluid milk), or (ii) in recombined and reconstituted other fluid milk products only; and/or (iii) in non-flavoured other fluid milk fortified with vitamin and mineral only; and/or (iv) in other fluid milks such as protein-adjusted milk, lactose-low milk, etc.

Despite of the lack of consensus noted in the report on many of these issues, the provisions under consideration are proposed for adoption (by the next CAC41) with specific notes reflecting the debate additive by additive, “for use in non-flavoured vitamin and mineral fortified fluid milk only”9, “excluding lactose-reduced milk”10, of with more specific level set as “Except for use in lactose-reduced milks at 500mg/kg”11. Nitrogen was also approved as packaging gas only.

The debate on the use of other food additives as emulsifiers and stabilizers in this food category was even more animated both during the pre-session PWG. The CCFA50 could only conclude about to a lack of consensus and did not endorse the PWG recommendation to recognise that those substances would generally be technologically justified for use in these types of fluids milk. Hence, all the provisions are retained on hold and it means that they will be re-discussed again one by one next year12.

  • Soft drinks, “ADI” and a moment of palpable tension

Although most of the discussions went well on other provisions, one topic has led to vivid exchanges between delegations on some provisions considered both at the pre-session working group and the plenary.

Everything started badly with the consideration of a provision of 10 mg/kg of dioctyl sodium succinate (INS 480) in water-based flavoured drinks (i.e. soft drinks), including ‘sport’, ‘energy’ or ‘electrolyte’ drinks and ‘particulated’ drinks. The EU representative made clear that (i) with a low JECFA Acceptable Daily Intake (ADI) for that substance, (ii)with the current proposed maximum use level, (iii) and considering that if a 20 Kg-body-weight (very) young child would be drinking just a few centilitres of such soft drink containing that additive, it would easily lead to exceed the ADI13.

The same type of argument was used again by the EU for the provision for tocopherols (INS 307 a, b, c). But this time it triggered a chained reaction by USA, Canada, Australia and their allies of the day (Senegal, Chile, Colombia, South Africa, Kenya and Palestine, supported by ICBA and ICGMA) which denounced (i) a misleading argument as distorting what a proper exposure assessment should be, which would constitute a worrying precedent in CCFA proceedings; (ii) the concept of ADI (life-time exposure basis so focusing only on one age group is not relevant); and, (iii) that tocopherols were re-evaluated recently by the European Food Safety Authority and did not lead to safety concerns.

However, the EU representative indicated that the EFSA evaluation was referring to the use it as a vitamin and the health guidance value was a Tolerable Upper Limit but that, at the 95th percentile, the exposure to infants would lead to five times the ADI at the proposed 1000 mg/kg level. During the discussion, the JECFA secretariat was asked to check (i) when tocopherols (as well as other food additives considered for that food category) were reviewed for the last time and (ii) whether JECFA performed a dietary exposure assessment back then. The JECFA secretariat carefully indicated the last reviews were in 1986, 1975, 1976, 1973 depending on the food additives mentioned, and pointed that the JECFA role was limited to establish an ADI at that time and no exposure assessment was done by or requested to JECFA back then. (And let’s remember: GSFA started to be reviewed in its modern feature from the early 1990s only).

At another point of the discussion on the other provisions for this food category, the JECFA secretariat also indicated that if CCFA would decide to ask JECFA to performan exposure assessment for a given additive, it could be that JECFA experts will consider that the food additive in question may also deserve a re-evaluation (given the last date of review by JECFA) and they decide to revisit the food additive specifications to check new methods of production or simply put the specifications in line with others, adopted at national/regional level. That’s where the discussion was left in the PWG on GSFA before the plenary revisits the issue.

Hence, the CCFA50 report contains an unusually long paragraph (Para.91) which spells out very clearly the (still) divergent points of views expressed during the plenary.

In terms of the provisions, five are going through for final adoption (including the one on tocopherols but with a new note added to it referring to the fact that in this case tocopherols are secondary food additives – and wasn’t it the whole point of the EU to challenge the technological needs and justifications provided in the first place about the draft level proposed initially at 1000 mg/kg?)14, and 8 other provisions are discontinued (two at the express request of the soft drink industry as they are used as flavouring not flavour enhancers)15. Therefore, all ended up well. And CCFA50 finished its agenda smoothly.

  • GSFA work for 2018/2019: some colours are back on the work program

CCFA50 decided to establish a new EWG on GSFA to go overall the pending provisions for miscellaneous additives (except those subject to specific issues to be resolved such as adipic acid, nitrites, nitrates or feedbacks expected from other Codex commodity committees), but not only. The most astonishing breaking news is that the work program of the EWG on GSFA also includes, to the surprise of most of the participants, all pending provisions in the step process for colours in candies (hard and soft), marzipans and nougats, decorations to confectionery, and chewing gum, to start with. This is the first time in the past eight years, that CCFA has decided to place any colour provision on its work program, in the context of the GSFA itself. Indeed, discussions stopped on colour (and sweeteners) a couple of years ago, because of the growing use of Note 161 to get provisions approved. And then, the Committee focused primarily on Note 161itself, and then Note 161 on sweeteners (see above).

At that occasion and in the specific context of the new work on colours, an industry observer stated that it intended to “develop a constructive dialogue with all interested parties based on (i) sound science, (ii) state-of-the-art food technology, (iii) Codex Alimentarius procedures, and (iv) the Preamble of the GSFA”. The observer further pointed out that the recent progress made by the CCFA, not only at this 50th session but also the three last. In this industry observer’s view, such progress “were good for (i) consumer health protection, (ii) fair practices for foods in international trade and (iii) global harmonization of national and regional regulations and standards on food additives”. A round of applause concluded the statement and to thank the USA delegates (Chairing the EWG and PWG) and all the other delegations for their hard work in speeding up exponentially the progress to reduce – and soon complete – the backlog of all pending provisions in the GSFA.

Other, more classic, CCFA50 decisions on Alignment, INS and JECFA list of priorities

  • Alignment: great achievement and one of the most important ongoing pieces of work

The revised provisions for aligning food additives permitted in Annexes to the Commodity Standard for Canned Fruits (i.e. mangoes, pears, pineapples) and all the Commodity standards for fish and fish products16. Those provisions aligned between the related food categories of the GSFA and each of the Commodity standards are included

in Appendix IV-Part A & Part B; Appendix V – Part B1&B2 of the CCFA50 report (pending CAC41 approval decision). All those commodity standards will accordingly be modified and republished during the second half of 2018 to reflect the changes.

CCFA50 adopted a very important working guidance document on alignment, included in Appendix XI of CCFA50 report. This document will be published as an information document on the Codex Alimentarius website17. The working guidance also includes a flowchart decision-tree and further specific recommendations to the active Codex Commodity Committees to start thinking to help CCFA in the alignment process of food additives provisions in Codex food standards under their responsibility and the corresponding food categories in the GSFA. CCFA50, therefore, agreed that commodity committees shall be informed about that document as well as all FAO/WHO regional coordinating committees which have developed regional standards in the last decade. They will also be informed about the alignment plan that CCFA has adopted at its 50th session, and specially request CCSCH, CCFO, and CCPFV to consider prioritizing initial alignment of commodity standards within the scope of the next two years. The full plan includes all Codex food standards. The full completion of the work is expected by 202518.

CCFA50 also approved a revised approach on how listing the corresponding commodity standards in Table 3 of the GSFA after having verified its applicability for the GSFA-online posting and how the information could be managed in the GSFA overall database and published version of CXS 192.

CCFA50 also requested other Codex Committees to revoke the permitted use for some food additives with no JECFA specification (i.e. potassium hydrogen malate (INS 351(i)), potassium malate (INS 351(ii)), monosodium tartrate (INS 335(i)), monopotassium tartrate (INS 336(i)) and dipotassium tartrate (INS 336(ii)) in several Commodity Standards which they are responsible for.

Therefore, it can be concluded that the alignment work will be the most substantive part of the work of CCFA for the next years, with Australia and Japan as the leading countries, and with new help from specialised industry observer organisations, such as the International Dairy Federation (IDF) and the Codex Commodity Committees, now that the operating rules and working procedures have been approved by CCFA.

  • Review of JECFA past work, current recommendations for CCFA consideration and CCFA decisions on next priorities of work for JECFA in the next 2 years

As usual, CCFA reviewed the outcome of the most recent JECFA meeting on food additives (held in June 2017) and considered whether any action may be necessary. It is worth noting that JECFA has re-evaluated two colours (Brilliant Blue FCF and Fast Green FCF) and reaffirmed that both did not raise any safety concern in terms of exposure (even if the ADI has been lowered in one case). Meanwhile, CCFA50 agreed with JECFA recommendation that the Group ADI for all carotenoids may be re-evaluated in the light of the information provided about a new algal source of beta-carotene.

CCFA50 also adopted several new and revised JECFA specifications (i.e. adopted as “Full” by JECFA) for possible adoption as Codex specifications for food additives (i.e. as international standards)19. Two new specifications for Tamarind seeds polysaccharide (INS 437 – assigned by CCFA50 to be approved by CAC41) and Beta-Carotene-rich extract from Dunaliella salina (No INS assigned yet, but it is on the agenda of the EWG on INS – see below). CCFA50 also adopted full revised specifications for Brilliant blue FCF (INS 133); Fast Green FCF (INS 143); Silicon dioxide, amorphous (INS 551); Sucrose esters of fatty acids (INS 473); Microcrystalline cellulose (INS 460(i)); Gum ghatti (INS 419); Sodium aluminium silicate (INS 554) and Steviol Glycosides (INS 960). These changes are reflected in Appendix III of CCFA50 report.

CCFA noted – for information only – other specifications currently under JECFA review (i.e., called “Tentative” by JECFA), pending additional information is provided to JECFA for their finalisation (e.g. Jagua (Genipin–Glycine) Blue; Metatartaric acid (INS 353); and Yeast extracts containing mannoproteins).

Regarding JECFA list of priorities assigned at this CCFA50 session, the most remarkable change is the addition of many enzymes (used as processing aids) to the list of priorities. The other remarkable additions relate to several applicants request to consider new types of steviol glycosides obtained according to various techniques ranging from the use of genetically modified microorganisms to bioconversion and biosynthesis. A new natural pigment extract named Black carrot extract is also added All JECFA new priorities are reflected in Appendix X of the CCFA50 report. Moreover, it should be noted that the table has been populated with a more formalised list of information fields, at the initiative of the Canada chair, aiming at keeping records on details of the initial requests, previously only recorded in working documents uneasy to find back20. Those new fields will also be reflected in the Codex circular letter requesting comments on new JECFA priorities each January. In addition, a new Annex will be added to such circular letter to ask applicants/sponsor countries responsible for substances already under the review process by JECFA to confirm (i) the interest in pursuing with the application and (ii) they would comply with the announced deadline for data availability.

In that context, it is also worth noting that another very important amendment has been agreed to be added to the Codex circular letter at the request of the JECFA secretariat (WHO side). That amendmentisplacedundersection9ofthecircular letter about the “list of data available”. It reads as follows: “For substances obtained from natural sources, characterization of the products in commerce and a relevant set of biochemical and toxicological data on such products are essential for JECFA to develop a specifications monograph and the related safety, and such data/information could include: components of interest; all components of the final products; detailed manufacturing process; possible carry-over of substances; etc.”

The addition of this paragraph primarily reflects the strong views of risk assessment scientific experts in JECFA that the safety evaluation and establishment of specifications for substances from natural sources shall not substantially differ from what is required for substances obtained by other methods. Indeed, “natural” does not mean necessarily “safe”. Some plants or organisms are indeed containing very toxic elements, sometimes deadly at low doses. And the soft methods used to extract other interesting parts of such plants or organisms (such as natural colouring pigments) may not necessarily phase out those natural toxicants.

This addition approved by CCFA may be viewed as anecdotal, however, it is a fundamental clarification. It should draw the attention of all companies having strategies or making ‘natural’ claims about concentrated colouring pigments, sold as “colouring foodstuffs” or “foods with colouring properties”. As a matter of fact, some of them exert a very similar colouring function in final foods than food additives (colors). And they are currently not subject to the same stringent risk assessment scrutiny and regulatory clearance as colour food additive (if any). Synthetic colours, on the other hand, have a known and constant composition. They have been re-evaluated and generally, no safety concerns based on their intended uses are generally concluded by JECFA or national competent risk assessment agencies.

  • CCFA50 followed all the recommendations prepared by its in-session EWG on the INS21, chaired by Belgium due to the absence of Iran representative

CCFA50 has adopted several changes to the Food Additive Class Names and International Numbering System (including functional classes and technological purposes) for food additives mostly based on the work done since the last session through an inter-session electronic working group and new proposals put forward. CCFA50 did set-up

an in-session physical working group which tuned up further those recommendations into concrete proposals to the CCFA50 plenary for adoption.

The most important CCFA50 decision relates to Steviol Glycosides (i) to change the way Steviol Glycosides are numbered in the INS; (ii) what it means with regards to the provisions adopted in the GSFA and (iii) consequential amendments to the relevant Codex document listing adopted JECFA specifications.

Changes to steviol glycosides listing in the INS are included in Table 3 of Appendix IX-Part.A2 of the CCFA50 report. The first change is that the entry corresponding to INS 960 becomes a parent category as “Steviol Glycosides” (therefore with no assigned functional class nor technological purpose for that parent category, as it becomes a “title” or class name of a broader family of food additives).

A new INS 960a is assigned to Steviol glycosides from Stevia rebaudiana Bertoni with possible synonym added in brackets “Steviol glycosides from Stevia”. That substance (which corresponds to the (only) one permitted in GSFA to date), is obviously a sweetener used for technological purpose as sweetener (i.e. for sweetening).

Another two new entries are introduced in the INS. INS 960b is now a sub-parent category of Steviol Glycosides to describe all steviol glycosides obtained “from fermentation”. That number has no functional class nor technological purpose consequently. Under this sub-parent category, a new entry as INS 960 b(i) Rebaudioside A from multiple gene donors expressed in Yorrowia lipolytica is created as sweetener and for the technological purpose of sweetener (i.e. for sweetening). That approach looks quite new and may raise consistency questions across the overall INS system. But that’s what is proposed for final adoption at the next CAC41 this July.

Furthermore, CCFA50 decided that in the Codex text listing the Codex-approved JECFA specifications for food additives (CAC/MISC 6 – CXM6), the two entries for INS960a and INS960b (i)would replace the current “Steviol glycosides” one. Consequential amendments are included in Appendix XI – Part B.

The other consequential decision taken by the CCFA50 is that all already approved provisions for Steviol Glycosides in the Codex GSFA will be applicable as a parent category entry into the GSFA to both new INS 960a and INS 960b (i), such as what is done for other food additives with a Group ADI and covered by a parent category (e.g. Phosphates). In concrete terms, it means that all the previously reviewed and approved use levels for Steviol Glycosides obtained by plant extraction from Stevia rebaudiana Bertoni will be also approved for Rebaudioside A from multiple gene donors expressed in Yorrowia lipolytica, as the maximum permitted use levels are expressed as steviol equivalent anyway.

Among other things, CCFA50 also approved other changes with a new functional class for (a) propylene glycol as a carrier and two corresponding technological purposes as carrier and carrier solvent, (b) mono- and diglycerides of fatty acids, as glazing agent and surface-finishing agent, (c) gellan gum as a gelling agent and (d) DL-malic acid as a sequestrant. Potassium poly aspartate has been added to the INS with number 456 as a stabilizer, with the technological purpose being also as a stabilizer. As mentioned earlier, Tamarind seed polysaccharide was also assigned a new INS number 437 as an emulsifier, stabilizer, thickener and gelling agents with corresponding technological purposes, plus as “foam stabilizer”.

All the adopted changes are reflected in Appendix IX Part. A2 and B.

  • CCFA50 endorsed provisions for food additives adopted in the Codex standard for dairy permeate powders but not for the Near East Regional standard on Doogh, thus delaying very much the publication of the standard approved by CAC40 in July 2017

CCFA50 endorsed with no difficulty the limited food additive provisions of the Codex Standard on Dairy Permeate Powders (developed by correspondence). It should be noted that the standard also contains a provision on processing aids.

However, CCFA50 was not able to find consensus on the food additives provisions enclosed in the Near East Regional Standard on Doogh based on the outcome of discussions held during the in-session working group on Endorsement and Alignment and the plenary. Indeed, this topic also led to very interesting discussions and a reminder about the relationship between Codex Committees elaborating commodity (i.e. food) standards and the GSFA when it comes to food additives.

Starting with the reminder, the USA reminded everyone, including the Codex Secretariat, that on page 50 of the English version of the CAC Procedural Manual, “Should the commodity committee consider that a general reference to the General Standard for Food Additives does not serve its purpose, a proposal should be prepared and forwarded to the Committee on Food Additives for consideration and endorsement. The commodity committee shall provide a justification for why a general reference to the General Standard for Food Additives would not be appropriate in light of the criteria for the use of food additives established in the Preamble of the General Standard for Food Additives, in particular, Section 3.” Based on this reminder, the CCFA did not get the technical inputs it needed to understand the technological needs for each of the individual provisions suggested in the standard.

It was recalled however that almost all food additives – but two (i.e. nisin and magnesium dihydrogen diphosphate) and the reference to national legislation were present also in the adopted international Codex Standard on Fermented Milk22, something that IDF tried to underline to the plenary.

IDF equally flagged out that there were transcription errors in the draft Regional Standard for Doogh, including in table 4.1 between heat-treated Doogh and heat-untreated Doogh compared to the Codex Standard on Fermented Milk. Japan also raised the issue of one type of Chlorophyllin which may need to be taken out from the list as not permitted in GSFA.

Finally, the USA indicated that the reference to national and/or regional competent authorities for the implementation of such provisions should not be present in such Codex standard and section on food additives unless duly justified as well. Indeed, that reference seems to close to the wording of Note 161 found in the GSFA.

As a consequence of all of the above, CCFA50 did not endorse the food additive provisions in the draft Near East Regional Standard for Doogh and requested that the CCNE consider at its next session (a) whether a general reference to the GSFA was possible in place food additive provisions in the draft Regional Standard and if not to provide a justification; (b) assess the detailed comments provided by Japan in CCFA50 CRD31 and (c) reconsider the reference to national legislation set in the footnote(a) of the Table of Section 4.1 of the draft regional standard. Given the time by which the next CCNE may convene its 10th session (especially if after next CCFA51 in March 2019), the finalization and publication of the Regional Doogh Standard may be postponed by one to two years, as CCFA is to give its final say on the food additive section again. Maybe that’s something which may be fixed before then perhaps through a discussion to be held on the side of – or during – a forthcoming CAC meeting.

Discussion on nitrates and nitrites

CCFA50 considered the outcome of an EWG on the matter led by the Netherlands which came back with more questions than definitive recommendations for consideration by the CCFA.

Based on several interventions and clarifications from the JECFA secretariat (both FAO and WHO sides) on this issue, it was clear that there is an obvious lack of clear-cut useful data, there is a thin line between what CCFA was doing on food additives and what CCCF was doing on contaminants regarding sources of dietary exposures to help JECFA refining all the aspects related to the risk(s) characterization, and a lack of visibility on the various risk management options. Based on that, CCFA50 agreed to task a new EWG chaired this time by the EU and co-chaired by the Netherlands to continue the investigation work and try to answer further some of the questions. More details are accurately reflected in paras. 94 to 104 of the CCFA50 report.

Discussion on further definitions of “plain”, “fresh”, “untreated”, “processed”, “unprocessed” (raw food or fresh food), “minimally processed (plain) foods”, “ultra-processed products” and possible related criteria for using food additives in them.

CCFA50 struggled a bit with the discussion paper prepared by the Russian Federation. Indeed, CCFA49 did ask the Russian Federation to prepare a document which would go into more details about Russia’s request to develop more precise Codex definitions about the terms “plain” and “unprocessed”, used and found in descriptors of the food categorization system included in the full GSFA (CXS 192). The discussion paper rather expanded the objective in trying to develop a set of new criteria to qualify, a priori, the suitability for the use of food additives in foods, depending on the level of processing they could have been subject to. Some countries were not in favour simply to continue working into that subjective direction, while others mentioned that what could be useful is to discuss the differences of concepts between “plain”, “fresh”, “unprocessed” and “untreated”.

CCFA50 tasked the Russian Federation to prepare a new discussion paper to review all existing Codex texts and identify where the terms “plain”, “fresh”, “unprocessed” and “untreated” were used and to what purpose to assess the feasibility and usefulness to develop definitions of these terms, for the purpose of allocating food additive provisions to those foods qualified with those terms.

Next CCFA session

CCFA51 will be held in China from 25 to 29 March 2019 and preceded by a physical working group on GSFA and maybe on Alignment.

More details about CCFA50 working documents and conference room documents (CRD) are available at www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCFA&session=50 http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCFA&session=50

Report of CCFA50 session is available at www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=ht tps%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcode x%252FMeetings%252FCX-711-50%252FReport%252FREP18_FAe.pdf

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1  The Codex GSFA is also known as CODEX STAN 192 (now CXS 192); it is composed of a preamble, several appendices (e.g. defining the hierarchic food categorizations system) and Tables 1 to 3 containing all adopted food additive provisions, as well as the list of Notes, specifying further conditions/restrictions of use for such provisions.
2  Food Engineer, Regulatory and Scientific Counsellor at Keller and Heckman LLP.
3  Food Law Attorney & Partner at Keller and Heckman LLP.
4  Both supported by many countries from Africa (Kenya, Senegal, Zimbabwe); the Americas and the Caribbean (Canada, Chile, Costa Rica, Colombia, Brazil, including Cuba); Europe and Asia Pacific (Russian Federation, UK, Germany, China, Australia).
5  Report of the 2015 UK-led EWG was gathered in CX/FA 15/47/13 working document of CCFA47 agenda item5g.
6  With the exception of those additives provisions with technological functions of colour or sweetener, adipates, nitrites and nitrates, and the provisions related to grape wines.
7  With the exception of food additives provisions with the function of colour and sweetener.
8  INS 474 provision currently approved at 10000 mg/kg in Sauces and sauce-like products.
9  INS 330, 472a, 472b, 472c, and 472e (each at GMP).

10  INS 300, 301, 322(i), 331(iii), 471, and 525 (each at GMP), 475 (at 1000mg/kg), 307a,b,c (at 200 mg/kg); 473, 473a and 474 (singly or in combination at 1000 mg/kg).
11  All phosphates (listed in GSFA) singly or in combination at 2200 mg/kg, expressed as Phosphorus.
12  INS 410, 407, 418, 412, 414*, 1440, 460(i), 440, 1200, 501(i)*, 466 and 415 (each at GMP), and 405 (at4000mg/kg) – those marked with * here are noted “For use in non-flavoured vitamin and mineral fortified fluid milk only”.
13  The EU representative showed what that amount would score on a small water bottle; Given his intervention was broadcasted on the meeting room screens, everyone could clearly see his dramaturgic illustrative gesture.http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252 Fsites%252Fcodex%252FStandards%252FCODEX%2BSTAN%2B243-2003%252FCXS_243e.pdf . CRD31 (Japan comments) are available at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252 Fsites%252Fcodex%252FMeetings%252FCX-711-50%252FCRDs%252Ffa50_CRD31x.pdf

14  INS 473, 473a, 474 (at 200 mg/kg singly or in combination, except for use in non-alcoholic aniseed-based, coconut-based, and almond-based drinks at 5000 mg/kg), INS 334, 335(ii), 337 at 800 mg/kg expressed as tartaric acid, and Tocopherols (INS 307 a, b, c) at 200 mg/kg as carry-over from use as an antioxidant in flavours, colours, juice ingredients and nutrient preparations.
15  INS 637*, 636*, 476, 430, 431, 405, 262(ii), 491 to 495 (* at the request of the soft drink industry).
16  Standard for Certain Canned Fruits (CXS 319-2015) and the Standards for Canned Salmon (CXS 3-1981); Canned Shrimps or Prawns (CXS 37-1991); Canned Tuna and Bonito (CXS 70-1981); Canned Crab Meat (CXS 90-1981); Canned Sardines and Sardine-Type Products (CXS 94-1981); Canned Finfish (CXS 119-1981); Salted Fish and Dried Salted Fish of the Gadidae Family of Fishes (CXS 167-1989); Dried Shark Fins (CXS 189-1993); Crackers from Marine and Freshwater Fish, Crustacean and Molluscan Shellfish (CXS 222-2001); Boiled Dried Salted Anchovies (CXS 236-2003); Salted Atlantic Herring and Salted Sprat (CXS 244-2004); Sturgeon Caviar (CXS 291-2010); Fish Sauce (CXS 302-2011) and Smoked Fish, Smoke-Flavoured Fish and Smoke-Dried Fish (CXS 311-2013).
17  Likely to be posted at http://www.fao.org/fao-who-codexalimentarius/resources/infodoc/en/
18  See page 148 and 149 of the CCFA50 report (English version).
19  For inclusion in a Codex standard called CAC/MISC 6 (i.e. CXM 6). See the March 2018 version at http://www.fao.org/fao-who-codexalimentarius/codex-texts/miscellaneous/en/. As such, CCFA does not develop its own specifications for food additives (and flavourings) but rather adopt those developed by JECFA.

20  Type of request, proposed by [sponsoring country], Year request was endorsed by CCFA, date of availability of required data in applicant dossier, data provider’s full name and details, basis for the request, Possible issues for Trade.
21  INS and Class names are published once a year as CAC/GL 36 (CXG 36). See the March 2018 version at http://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines/en/