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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

This article was first published by EU Food Law on March 19, 2019.

Marketing Cannabidiol (CBD) in the EU has become more complex and, in some cases, is subject to national restrictions.

Shops selling products containing Cannabidiol (CBD) are popping-up across Europe drawing more and more attention on the legality, write Katia Merten-Lentz and Manon Ombredane of international law firm Keller & Heckman.

Cannabis sativa L is a well-known plant made up of more than 480 compounds, including over 100 cannabinoids composed of both psychoactive and non-psychoactive compounds[1] including CBD. CBD contained in food products like tinctures is often derived from the industrial hemp variety cannabis sativa L. which contains low level of Delta-9-tetrahydrocannabinol (THC)[2] (<0,2%).

Setting aside the question of the classification of cannabis under International Drug Control Conventions[3] and the possible safety issue related to the presence of THC, food containing CBD must – as any other foodstuff – comply with the food legislation. This includes Regulation (EU) 2015/2283 on novel foods[4] as well as the general principle set out under the General Food Law[5] according to which food must not be unsafe[6].

Novel foods catalogue modified

What recently caught the attention of national authorities across Europe, as evidenced by the multiplication of RASFF notifications, is the European Commission decision to modify the Novel Food catalogue.  In a recent meeting of the European Commission’s Working Group on Novel Food, the European Commission and the Member States agreed to modify the entries related to cannabis sativa L, cannabidiol and cannabinoid in the Novel Food catalogue in a tentative to clarify the regulatory landscape for food products containing CBD.

Accordingly, the new entry for Cannabis Sativa L. is now clearly stating that:

“In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 % (w/w). Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities”

In parallel, the new entry for “Cannabinoids”[7] provides that:

“The hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9-tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9-THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel

Generally, a food which a has not been used for human consumption to a significant degree within the Union before 15 May 1997 and which falls within the categories set out under Article 3(2)(a) of the Regulation (EU) 2015/2283 on novel foods [8] must be subject to a risk assessment and authorization prior to the placing on the EU market. During a previous meeting of the Working Group on Novel Foods[9], the European Industrial Hemp Association (EIHA) was invited to present arguments supporting the fact that hemp extract containing CBD should not be considered novel,[10] notably based on its history of safe use in the EU. But, following the meeting, it seems that none of the EIHA arguments could convince the European Commission and the Member States to consider hemp extract containing CBD as not novel.

Accordingly, the way forward for business operators decided to sell hemp extract and derived products containing CBD in the EU is to go through the Novel Food procedure set out under Regulation (EU) 2015/2283. To this date, only one dossier has been submitted to the European Commission aiming at supporting the safety of cannabidiol as novel food in food supplements for adults at a daily intake of up to 130mg or 1,86mg/kg[11].

Member state differences

On the other side, for products that may contain CBD such as “seed oil” but which are not novel due to their history of consumption in the EU, the placing on the EU market is not simple as well. As pointed out under the entry for Cannabis sativa L. “other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States.

This is for instance the case in Belgium that restricts the marketing of food derived from Cannabis Sativa L. The plant is listed in the List 1 “Hazardous plants that cannot be used as or in foodstuffs” of the Royal Decree of 29 August 1997 on the manufacture of and trade in foodstuffs composed of or containing plants or plant-based preparations.

Hence, even though the recent modification of the Novel Food catalogue may have brought some clarity regarding the novel food classification, business operators wishing to market CDB on the EU market must avoid other pitfalls and notably, they must pay attention to possible national restrictions that may apply to food products derived from Cannabis sativa L.


[1] See European Parliament Motion for a resolution on use of cannabis for medicinal purposes (2018/2775(RSP)), 13 February 2019

[2] Main psychoactive constituent of cannabis

[3] In this respect, the World Health Organization recently recommended rescheduling cannabis and its chemical components under international drug treaties.

[4] Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, OJ L 327, 11.12.2015, p. 1–2

[5] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, amended

[6] Article 14 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law

[7] The entry for CBD refers to the entry “cannabinoids”

[8] E.g. food consisting of, isolated from or produced from plants or food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances.

[9] Held on 16 October 2018

[10] EIHA presentation is available at: http://eiha.org/media/2019/01/18-10-16_NF-WG-EIHA-Presentation-Released-final.pdf

[11] Request for a scientific opinion on trans-Cannabidiol as a novel food (NF 2018/0349) (EFSA-Q-2018-00512)

This article originally appeared in World Food Regulation Review, Vol. 28, Number 9, February 2019.

This article aims to present and explain the main topics on the agenda of the forthcoming 51st session of the Codex Alimentarius Committee on Food Additives, taking place in Jinan from 25 to 29 March 2019.

In next month’s WFRR issue (March), a similar article will summarize the main decisions resulting from CCFA51.

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The forthcoming 51st meeting of the Codex Alimentarius Committee on Food Additives (CCFA51) is expected to finalize most of the backlog on food additives, other than sweeteners and colours. For the first time since 2011, CCFA51 will also address pending drafts for provisions for the remaining colours in three food subcategories belonging to Confectionery for possible adoption in the Codex General Standard on Food Additives (GSFA). CCFA51 will also discuss important matters relating to nitrites and nitrates, as well as concepts such as “plain”, “fresh”, “unprocessed”, “untreated” and possible reinforced principles for using food additives in food categories containing these qualifiers in the GSFA. CCFA51 will try to make progress as well to find alternative options for a revised wording – or a full replacement by new notes – of the famous Note 161 throughout the GSFA in the context of sweetener provisions. CCFA51 will also address an important issue relating to the use of parent names of food additives and the procedure by which such groupings could affect food additives permitted in the GSFA. CCFA51 will also review its regular yearly items such as alignment between GSFA and commodity standards, endorsement of provisions included in draft commodity standards developed by other Codex Committees, amendments to the international numbering systems and functional classes of food additives, set the future priorities of JECFA upcoming scientific evaluations, and endorsement as a Codex norm of a series of new or revised specifications of identity and purity for a couple of food additives.

The 51st session of the Codex alimentarius Committee on Food Additives will be held in Jinan (China) from 25 to 29 March 2019, preceded by an important presession working group in person (PWG) to advance recommendations to the CCFA51 plenary. This PWG builds on recommendations from an electronic working group (EWG), which has advanced discussions on a large number of draft provisions for miscellaneous food additives and colours, particular uses in plain milk products and mozzarella, and on new proposals to add certain provisions of the GSFA or revise others.

GSFA: completion on almost all remaining miscellaneous additives and resuming discussion on a few colour provisions, among other discussions on plain and flavoured milk, mozzarella, soft drinks, etc.

Draft provisions on miscellaneous food additives in the whole GSFA and on the inclusion in Table 3 of the GSFA of two additives for approval – i.e. at GMP level unless otherwise specified. This is the long-awaited final discussion on most of the remaining draft provisions for miscellaneous food additives other than sweeteners, colors, adipic acid and other exceptions, which are to be addressed separately by CCFA at this session and at a later stage.

Draft provisions will be discussed in almost all food categories. This is by far the biggest piece for the PWG and the CCFA51 plenary. It will include draft provisions mainly for emulsifiers, thickeners, stabilizers, antioxidants, bulking agents, carriers, color retention agent, acidity regulators, emulsifying salt, etc.

A consensus is expected to be found on most of the provisions, except where some Codex member countries are of the opinion that an insufficient technological justification has been provided during the EWG past 8 months discussions. There will also be some discussion about the provision of propylene glycol in carbonated and non-carbonated water-based flavored drinks, whereby it may reignite the debate on secondary food additives (in flavoring and other preparations) vs carrier food additive. We recommend interested readers to read Annex 4 of the CCFA51 agenda item 5a working document available at www.fao.org.

There is also a proposal to include two food additives in Table 3 of the GSFA, namely Gum Ghatti (INS 419) and Tamarind Seed Polysaccharide (INS 437). Once formally approved in Table 3 of thGSFA, it means that their use will be permitted at GMP level in all food categories not annexed to Table 3. The two additives may be considered admissible in those food categories annexed to Table 3 if and only if comments are submitted in the coming months for suggested uses and numerical use levels in food categories annexed to Table 3 for discussion and possible future adoption in Table 1 and 2 at CCFA52 and beyond. CCFA51 will address other uses already approved in some specified foods covered by some Codex Commodity Standards, where these two food additives may be considered as technologically justified by the means of tables annexes to Table 3 of the GFSA or in the context of the on-going alignment work.

Colours for three sub-food categories of Confectionery

Last year, CCFA50 decided to initiate an experiment to see whether the international food additive community could discuss and possibly agree on all pending provisions for colours in three specified food categories and their subcategories to start with (see WFRR April 2018 issue). This year PWG and CCFA51 will consider recommendations to adopt most of the proposed colour provisions in (i) decorations for confectionery products, (ii) hard and soft candies and (iii) chewing gum. On the willingness of country blocks to find consensus around the EWG recommended maximum use levels for adoption (resulting from three rounds of negotiations among 55 countries from all over the world), will depend whether CCFA is able (i) to adopt such provisions for colors in the GSFA for the first time since 2011 and (ii) agree to continue the consideration of other colour provisions in the step process for other food categories. It should be noted that in the course of the three rounds of negotiations, the food industry provided massive contributions for the (i) technological justification of use, (ii) technological needs and (iii) consent to reduce the initially proposed draft maximum levels currently in the step process.

Therefore, it would be unfortunate that some country delegations nevertheless deny the fact that such justifications have been duly provided, even though some of the proposed levels may be higher than or not present in their respective national/regional legislation. On that point, the forthcoming PWG discussion will be symptomatic of whether country blocks may approach these Codex negotiations as such or would invoke their national legislation to hinder the adoption of those provisions in the Codex GSFA. It has also a potential risk to reopen the same wounds which led CCFA to stop considering color provisions since 2011. Everyone hopes this won’t be the case and that wisdom and constructive spirit may prevail in 2019.

Plain and flavoured milks

The PWG and CCFA51 will also discuss the technological justification of the use of trisodium citrate at GMP level in “Plain milk”, especially in plain milk obtained from other species than bovine species. However, opinions are clearly split as reflected in the proceedings of last year CCFA. Cur- rent proposal is to allow the use only as emulsifier or stabilizer. However, such use is disputed heavily in the case of cow and other bovine milks. Therefore, some argue that the allowed use of trisodium citrate should be limited to milks from non-bovine species. Others in favor of this use in cow milk argue that limiting it to sterilized and UHT treated only cow milk could resolve the matter. Dairy industry seems to be on that side and the recommendations of the EWG reflect this view. It is expected that those who expressed support for use only in non-bovine milk at the last session (e.g. EU Russian Federation, Uganda during the EWG and Costa Rica during last year CCFA) may raise again their concerns about these recommendations.

The other controversial issue is whether emulsifier and stabilizer such as carob bean gum, carrageenan, guar gum, gellan gum, etc. are justified in all products covered by this (new) food cate- gory named “Other fluid milks (plain)”. This relates also to the qualifier “plain” to describe adequately what those fluid milks are. It seems that the intent to use those substances relate more to some subcategory of products, which, although milk-based, would be slightly different from plain fluid milks, e.g. flavored and enriched in vitamins and minerals fluid milks, as pointed out last year. The current EWG recommendations, which obviously result from an attempt to find a middle ground, aim at approving numerical use levels for each substance in the full category of products covered by “Other fluid milks (plain)”, but leave opened the GMP level option for the whole food category as well. It also suggests an exemption at GMP level for “milk-based beverages only”. Reference to fortified and flavored fluid milks have clearly not been pursued forward by the EWG, compared to last year CCFA meeting discussions.

Mozzarella with high moisture

Another quite contentious point is on the agenda: whether the uses of preservatives in and anticaking agents for surface treatment of mozzarella with high-moisture content conforming to the Codex Commodity Standard for Mozzarella (CXS 262-2006) are technologically justified. The EWG recommends however that (i) the use of anti-caking agents in the surface treatment of “high-moisture mozzarella” is technologically justified only when that mozzarella is in a shredded or diced format and (ii) the use of preservatives in the surface treatment of high-moisture mozzarella is technologically justified when that mozzarella is not packaged in liquid. As a consequence, it recommends amending the table of food additives permitted in high-moisture mozzarella set in the Codex commodity standard for mozzarella, with two additional notes: (i) to permit but limit the use of all preservatives “only for high-moisture not packaged in liquid” and (ii) to permit but limit the use of all anti-caking agents to “surface treatment of shredded and/or diced cheese, only”. (Note of the author: maybe “cheese” could be changed to high moisture mozzarella…). We shall still see how the Italian delegation will react, but it seems the proposed approach could constitute an acceptable compromise for standardized mozzarella, which are clearly different from those mozzarellas with PGIs in Europe.

Water-based flavoured drinks and coffee/tea-based ready-to-drink beverages

The EWG recommendations aim at resolving two types of contentious concerns among countries. The first one relates to the sub-types of products where additives like stearoyl lactylates, polyglycerol esters of fatty acids, and moreover dioctyl sodium sulfosuccinate may be technologically justified for use, depending on the food cate- gory and the food additive considered: e.g. only in fruit-flavored beverages; use level expressed on a served-to-the-consumer basis; or ready-to-drink products and protein containing beverages; and/or for use in beverages which contain beverage whiteners only. The second issue relates to dietary exposure assessment based on the proposed maximum levels and the JECFA’s acceptable daily intake (ADI), and whether this is acceptable or not from a food safety risk management point of view. The PWG is expected to progress case-by-case on each provision separately and it may revive the unconcealable views already expressed during last year CCFA. Very difficult to predict whether consensus may be possible on all the recommendations for approval.

Other

The CCFA51 plenary will be tasked to respond to a request raised at the last July Codex Commission session about “the justification for the inclusion of Rebaudioside A from multiple gene donors expressed in Yarrowia lipolytica (INS 960b(i)) in the GSFA.”

Two levels of discussion are expected to occur: on the procedure itself; and probably on the principles for such similar changes to GSFA as well. This is the case when similar food additives are subject to a parent food additive category (i.e. which is generally done under the agenda item on the INS), generally because JECFA assigned a group ADI to all the similar food additives covered by such a parent category. The third aspect is that there are different possible (national) interpretations on how the use of such similar food additives would be declared on the food label in the list of ingredients, for instance only by referring to the name of the parent category, and not to the specific name of one of the added similar food additive covered by that parent category. This labelling aspect is, for the time being, not in the scope of the question which has emerged from the last Codex alimentarius Commission. The Codex INS is not to be used for labelling purpose, as in theory the INS is just an inventory, but in practice it is used differently at the national level.

This topic, which may appear a bit technical at first sight, is fundamental. The last year CCFA decision to introduce a parent category in the INS numbers for all types of “Steviol Glycosides” and the creation of two new INS under that parent category has led automatically to permit Rebaudioside A from multiple gene donors expressed in Yarrowia lipolytica (i.e. a type of steviol glycoside obtained by a genetically modified microorganism) in the same food categories and at the same maximum use levels which were already permitted for the steviol glycosides obtained by extraction from the plant Stevia rebaudiana Bertoni (i.e. Steviol glycosides from Stevia).

At this point in time, it is still uncertain up to which point CCFA51 may be able to have an in- formed discussion on all those issues, beyond the question of clarification on the procedure coming from last CAC. However, the question will also be raised when CCFA51 is to consider the recommendation to create for instance a parent category for e.g. “Sucrose esters” to cover all the uses of three food additives within the same JECFA group ADI, i.e. (i) sucroglycerides (currently INS 474), (ii) sucrose esters of fatty acids (currently INS 473), and (iii) sucro-oligosaccharides (SOE) of type I and II (currently INS 473a). In this case, it has to be further discussed what would be the INS number and the name allocated to the parent category, and what would be the expected revised sub-numbers for these three food additives. The wider principle discussion of creating a parent category will also be at the heart of the discussion, such as what it would mean for existing provisions for one or more of the three food additives. Indeed, which choice is to be made when two or more of the three additives may be permitted in the GSFA at different maximum levels in the same food category (i.e. which level to pick for the group? The highest, the lowest, a middle ground?)? And obviously that recommendation would lead to extending the use all three food additives singly or in combination wherever at least one of them is permitted in a food category (alike what happened with the new Rebaudioside A approved last year) without any case by case discussion of the technological justification in each food category. Indeed, food additives may have the same toxicological profile which justifies a group ADI; but is that the same for the technological purposes and needs? In other words, does a group ADI always mean automatically that all food additives are equivalent from a food technology point of view? It may be true for Phosphates, Anthocyanins, or Benzoates. But for others?

Possible new principles for the use of food additives in food categories with qualifiers such as “plain”, “fresh”, “unprocessed”, “untreated”

Russia has prepared a discussion paper to com- pile within the overall set of texts adopted by the Codex alimentarius Commission (Commodity Standards, GSFA food categorization system, Guidelines, Code of Practices) where the qualifiers “plain”, “fresh”, “unprocessed”, “untreated” are being used. The discussion paper aims also at assessing what it may mean in terms of the range and extent to which food additives shall be permitted in such foods.

From the Russian point of view, the idea is to establish further principles or criteria to restrict further the use of food additives proportionally to the level of processing. It also corresponds to what is currently not permitted to do according to the Eurasian Economic Union (EAEU) regional standard regulating food additives in its member countries (i.e. in the Russian Federation, Kazakhstan, Belarus, Armenia and Kyrgyzstan). It also corresponds to some advocacy movement, fed by some WHO-related think tanks, that ultra-processed foods are bad because ultra-processed foods contain food additives and reversely unprocessed foods are healthier because they don’t contain food additives. However, to date, no causal link has been scientifically demonstrated that e.g. organic foods are significantly healthier than conventionally produced foods. Only a few epidemiological studies have found some statistical correlations, however none of them have been able to explain the scientific reasons for such mathematical findings.

Nitrites and Nitrates

The discussion paper is not available at the time this article is drafted. This discussion paper is elaborated by an EWG chaired by the EU and co-chaired by the Netherlands and results from last year CCFA50 discussion and lack of consensus to take any risk management decision. The paper is to address some of the missing knowledge about nitrates and nitrites.

This discussion paper is expected to contain an inventory of data available on nitrates and nitrites, taking into account what was already compiled in last year CCFA working document on nitrites and nitrates as well as the written comments of the joint FAO/WHO JECFA Secretariat. That inventory shall contain:

(i) collected general information on risk-management approaches on nitrates and nitrites used as food additives by regulatory agencies of Codex members;

(ii) collected information on what is the most appropriate way of expressing the MLs in relation to control purposes, international trade, different production processes;

(iii) collected information on which types of products or production processes are nitrates and nitrites used, for what purpose and at what levels? What MLs expressed as ingoing and residual amounts are needed for preservation and color retention? Are there alternatives to nitrites and nitrates available for each of the GSFA subcategories for which provisions on nitrates and nitrites exist (whether adopted or in the Codex Step procedure) – and if available, provide accompanying data and studies demonstrating the effectiveness of the levels in performing the desired technological function;

(iv) collected information on natural occurrence data on nitrates and nitrites; and

(v) collected available information on remaining questions to further consider feasibility and the need for risk assessment. Namely:

(a) Does exposure to nitrosamines (exogenous and endogenous) pose a health risk? What are recent exposures from all sources and from food additives to nitrosamines generated during: i) the production process in foods; ii) heat-treatment in the domestic setting; and iii) gastrointestinal transit?

(b) What are appropriate levels (ingoing and residual) necessary to inhibit Cl. botulinum in view of risk (nitrosamines, ADI being exceeded) and benefit (microbiological safety) considerations taking into account other factors affecting microbial growth? and,

(c) To what extent does the use of additives such as ascorbic acid in conjunction with nitrates and nitrites reduce nitrosamine formation and mitigate the potential health risk from the use of nitrates and nitrites? Is available information enough to allow the safe use of nitrates and nitrates at higher levels when used in conjunction with these additional additives?

It may be quite a lot to digest and CCFA51 may only focus on the two first aspects described under (i) and (ii) above. See next month’s WFRR article on CCFA51 outcome…

Note 161 in the context of sweeteners

The discussion paper was not available at the time this article was written. This discussion paper was elaborated by an EWG co-chaired by the EU and the USA but was unfortunately delayed because of the US government shutdown at the end of 2018. Thus, the third circular with suggestions to find a compromise wording and alternatives notes to the note referring to national legislation and to the section on the principles for use of food additives in the preamble of the GSFA (i.e. “Note 161”) has not yet been shared either. It is unclear how the co-chairs are going to resolve the issue before CCFA51. According to reliable sources, the most likely scenario is that they are going to skip the third circular of the EWG and will produce a ‘two co-Chair’s proposal’ rather than an official recommendation resulting from a consensus within the EWG. This discussion paper will then be discussed by the CCFA51 plenary. It is not part of the man- date of the pre-session PWG in Jinan. The two co-chairs final proposal will be based on the draft solution presented in the EWG second circular draft, taking into consideration the very contradictive comments they have received in response to that second circular, and what they think may have a chance to be acceptable by all directly involved stakeholders and countries. More detail in nextmonth’sWFRRarticleonCCFA51outcome…

Other CCFA routine issues (Endorsement, Alignment, INS, JECFA, Endorsement)

Endorsement

CCFA51 will review draft provisions for food additives in the following draft standards developed by the Codex Committee on Spices and Culinary Herbs (CCSCH): dried or dehydrated garlic; dried oregano; dried roots, rhizomes and bulbs – dried or dehydrated ginger; dried leaves – dried basil; dried floral parts – dried cloves; saffron. The endorsement is expected to be straight forward.

However, under the “matters referred” CCFA51 agenda item, it is interesting to note the question from the last CCSCH with regard to (i) the use of anticaking agents in culinary herbs sold in powdered form to maintain “the free-flow characteristic of the products” with a particular focus on GMP levels for magnesium stearate and silicon dioxide and (ii) a clarification by CCFA on “how processing aids could be addressed under the Section 4 “Food additives” in accordance with relevant pro- visions in the Codex Procedural Manual?” The two matters are linked. Silicon dioxide for example can be viewed in some national jurisdictions as a processing aid e.g. used in milk powder silos as a free-flow agent, whereas in other national jurisdictions (or even at the same time in the same jurisdiction) it could be viewed as a food additive exerting the anticaking property in the final food (weigh protein powders for sportive people). This is a complicated topic and CCFA discussion may light up an interesting debate for possible future work of the CCFA on processing aids versus food additives, including the tricky issue of “residues”.

Alignment

A dedicated pre-CCFA51 session’s Saturday afternoon PWG will discuss the report from an EWG chaired by Australia on proposals to align certain food additive provisions in commodity standards with their related food categories in the GSFA. Pro- visions relate to (i) 13 cheeses standards (e.g. Camembert, Gouda, Emmental, Provolone, etc.); (ii) honey; (iii) sugars; (iv) natural mineral waters; (v) Bottled/packaged drinking waters (other than natural mineral waters); (vi) wheat flour; (vii) couscous; (viii) instant noodles; (ix) wheat protein products including wheat gluten; (x) Vegetable protein products (VPP); (xi) Soy protein products and their related food categories in the GSFA, e.g. 01.6.2.1 Ripened cheese, includes rind.

The approach will be to permit food additives in commodity standards in the future by functional groups and reference to Table 1 to 3 of the GSFA, instead of individual provisions, as per present provisions in the commodity standards. In other words, the current individual food additive provisions for example Cheddar will be deleted and re- placed with a table permitting e.g. colors, acidity regulator, preservatives, anti-caking agent, either in the cheese mass and/or in the rind/surface treatment. No doubt that the general issue of 1 to 1 correspondence with the GSFA food category descriptors will also be part of that discussion. CCFA51 plenary will take decisions based on the recommendations from that pre-session PWG report.

Review of JECFA past work, current recommendations for CCFA consideration and CCFA decisions on next priori- ties of work for JECFA for the next 2 years

JECFA86 outputs

CCFA51 will discuss the outcome of last meeting of JECFA (86th meeting, June 2018). Limited decisions are expected to be taken by CCFA51 from that report. JECFA86 conclusions relate to the following substances:

Anionic methacrylate copolymer (AMC): JECFA86 was unable to complete the evaluation of AMC. More data is required to clarify the in vivocarcinogenic potential of the residual monomer methyl acrylate.

Basic methacrylate copolymer (BMC): JECFA86 assigned an ADI “not specified” and established new specifications. JECFA recommends BMC (INS 1205) for inclusion in Table 3 of GSFA and circulate for comments at Step 3, and parallel request for use levels in food categories not covered by Table 3 for further discussion in Table 1 and 2.

Neutral methacrylate copolymer (NMC): JECFA86 assigned an ADI “not specified” but only temporary because of tentative specifications due to absence of data submitted for a suitable method of assay.

Sorbitol syrup: JECFA86 confirmed the assignment of an ADI “not specified” for sorbitol syrup.

Erythrosine: Full reevaluation and no reason to revise the previous ADI of 0–0.1 mg/kg body weight, which is confirmed as new ADI.

Indigotine: Full reevaluation and no reason to revise the previous ADI of 0–5 mg/kg body weight, which is confirmed as new ADI.

Lutein and lutein esters from Tagetes erecta and zeaxanthin (synthetic): JECFA86 assigned a group ADI “not specified” for (i) lutein fromTagetes erecta, (ii) lutein esters from Tagetes erecta and (iii) zeaxanthin (synthetic), but couldn’t conclude about meso-zeaxanthin, as no specification is currently available for meso-zeaxanthin. JECFA86 also revised the specifications for lutein from Tagetes erecta and kept unchanged specifications for lutein esters from Tagetes erecta and zeaxanthin (synthetic).

As such, JECFA86 recommends CCFA51 to include lutein from Tagetes erecta (INS 161b(i)) and zeaxanthin (synthetic) (INS 161h(i)) in Table 3 of GSFA and circulate for comments at Step 3, together with request for uses and use levels of the group food additives for the food categories listed in the Annex to Table 3 for future discussion and possible inclusion in Table 1 and 2. This JECFA recommendation is important as there are current draft provisions for zeaxanthin, synthetic proposed for adoption in the GSFA for candies, chewing gum and confectionary decorations.

Spirulina extract: JECFA86 assigned an ADI “not specified” but kept it temporary because the specifications remain tentative until further analytical data is provided, probably in December 2019.

Flavouring agents: JECFA86 completed the evaluation with no safety concern for almost all of them (about 70), but one. JECFA86 noted that genotoxicity data for p-mentha-1,8-dien-7-alraised concerns for potential genotoxicity. JECFA86 indicated it also couldn’t re-evaluate(+)-carvone according to the revised Procedure because of the lack of information on the oral expo- sure from all sources and the need to review the ADI. A review of the ADI is recommended based on the evaluation of all biochemical and toxicological data. Also, data is needed for an exposure assessment for oral exposure to (+)-carvone from all sources to complete the evaluation for (+)-carvone. It couldn’t re-evaluate (-)-carvone according to the revised Procedure either given the lack of information on the oral exposure from all sources and the lack of toxicological data.

Priority List of JECFA scientific advice to CCFA on food additives, flavourings and enzymes

CCFA51, most likely with the help of a possible in-session WG, will review the various requests received for revising the established list of JECFA priorities. CCFA51 will decide about their relevance and urgency. The requests may be grouped as follows:

– Safety evaluation and establishment of specification (new substances) Fulvic acid (i.e. 7,8-dihydroxy-3-methyl-10- oxo-1H,10H-pyrano[4,3-b]chromene-9-carboxylic acid), supported by South Africa for a South African company sponsor.

Riboflavin from Ashbya gossypii (sponsored by EU Specialty Food Ingredients). 46 flavorings, which include 45 new flavorings, 1 material for re-evaluation due to substantial new data since its original evaluation (sponsored by IOFI).

– Change to existing specifications

Change the solubility criterion from “sparingly soluble in ethanol” to “practically insoluble or insoluble in ethanol” in the specification ofPolyvinyl alcohol to (supported by EU for a Japanese company sponsor, via a law firm based in Belgium).

Change of the Method of assay from the “ICP-AES technique” to a titration method laid down in the monographs of the USP-Food Chemical Codex and other pharmacopoeia monographs (sponsored by CEFIC) in the specification of Magnesium stearate.

Replacement of the “congealing range” identification parameter by ‘Identification test — by acid value, iodine value, gas chromatography’ for three out of the five sorbitan esters approved in the GSFA (sponsored by EFEMA on behalf of a Danish company). 14 flavorings for which updated specifications data have become available (sponsored by IOFI).

– Reminder on pending priorities already on the list and confirmation of dossier/data availability

AMFEP expressed impatience through a reminder about all pending enzymes already included in the JECFA priorities table.

ETA (Enzymes Technical Association) reminded in their written submission that data is available for pending evaluation of D-Allulose 3-epimerase from Arthrobacter globiformis ex- pressed in Escherichia coli.

Codex approval as international norms of JECFA new and revised specifications of identity and purity

CCFA51 will review the outcome of the last JECFA86 to discuss whether new or revised specifications can be adopted as Codex standards. One specification was completed for Basic methacrylate copolymer (BMC). JECFA86 completed the revision of specifications of (a) Cassia Gum, (b) Erythrosine, (c) Glycerol ester of wood rosin (INS 445(iii)), (d) Indigotine; (e) Lutein from Tagetes erecta and a bunch of flavourings.

JECFA86 also advanced some tentative specifications, e.g. for individual modified starches.

For Spirulina extract, JECFA will have to complete the tentative specifications, when data are submitted by the sponsor on (a) full compositional characterization of commercial products in both liquid and powder forms; (b) full compositional characterization of the mulation/standardization; (c) validated analytical methods for identification of the substance with a suitable specificity (including validation data and representative batch data); and, (d) validated analytical methods for the determination of the purity of the substance with a suitable specificity (including validation data and representative batch data). This submission and further JECFA review work is expected to be completed by end 2019 and finalized full JECFA specifications submitted for Codex approval at the 2020 CCFA52 session.

International number system and functional classes/technological purposes

CCFA51 plenary will review the recommendations from a dedicated EWG and the related comments. Only a few, but significant changes are put forward.

EWG recommends the deletion from the INS of the following food additives (a) Red 2G (INS 128); (b) Sodium sorbate (INS 201); (c) Potassium ascorbate (INS 303); and (d) Distarch glycerol (INS 1411).

EWG recommends allocating the existing INS number to ˜-carotene-rich extract from Dunaliella salina by simply renaming Carotenes, beta-, algae as ˜-carotene-rich extract from Dunaliella salinawith existing INS 160a(iv).

Only one other change has been suggested to add a new functional class “Carrier” and two related technological purposes as “Carrier” and “encapsulating agent” to Methacrylate copolymer, basic (INS 1205), in addition to existing functional class and technological purpose as glazing agent (al- though JECFA has reviewed the safety of use of that additive only for its initial intended use of glazing agent of food supplements only).

In relation to the discussion on matters referred from the last Codex Commission, CCFA51 may also have to have a discussion of the impact of the parent category approach in the context of the discussion on the INS.

Although the proposed changes are not expected to be technically complicated to resolve, it may lead delegations to more fundamental questioning on the role of the INS as a simple inventory and al- location of a number, or as a Codex norm recognised by WTO/SPS/TBT Agreement as a “standard”. It may also lead to questions whether it is suitable to keep a substance in the list of approved Codex specifications if the substance is deleted completely from the INS. The current suggestion of consequential changes to the Codex text listing the Codex approved JECFA specifications to simply delete the INS reference number for Red 2G seems a bit contradictory to the fact that Codex would not view Red 2G as a suitable food additive any longer due to safety concerns after having deleted all the approved and pending provisions for Red 2G in the GSFA. In other terms, it is not because it will still be possible to have access to the specification for Red 2G in the JECFA database online, that the reference of Red 2G in the Codex document listing all the Codex approved JECFA specifications should be retained. One may argue it should also be completely deleted from that document as well. In other words, one may argue that there cannot be included in the Codex-approved JECFA specification list if the substance has been deleted from the INS list and/or from the GSFA.

Other matter referred

Based on a request coming from the before last meeting of the Codex Alimentarius Executive Committee (CCEXEC), CCFA51 is asked to provide its technical input about the new work under- taken by the Codex Committee on Food Hygiene (CCFH) to develop Guidelines for the management of (micro)biological foodborne crises/outbreaks and in particular reflect on whether similar guidance would be viewed by CCFA as needed in the context of microbiological contamination (and therefore criteria) of food additives, flavourings, enzymes or processing aids, as per the CCFA man- date and most likely JECFA specifications of identity and purity or other risk management options (dedicated CCFA guidelines).

This article originally appeared in World Food Regulation Review, Vol. 28, Number 9, February 2019.

The European Union (EU) succeeded in implementing one of the world’s highest standards of food safety. But each food scandal brings to light new gaps in the legislation and enforcement. After the Spanghero case (the so-called “horse meat scandal”), it is time again for public bodies to propose further steps to protect both food business operators and consumers against food fraud.

By Mrs Katia Merten-Lentz
with the support of Thais Payan

In response to the mad cow crisis (so-called “Bovine spongiform encephalopathy, BSE”), the European Commission created in 2002 a specific legal framework for food law. Every food business operator along the food chain, from the farm to the fork, must commit themselves to selling only 100% healthy and safe food.[1]

Traceability has also been strengthened, during manufacturing, but also upstream (ingredients used) and downstream (customers to whom the products are delivered).[2] In 2013, the horse meat crisis showed how creative fraudsters can be in finding ways to circumvent the broad and strict rules enforced in the EU. It brought to light the absolute necessity of cross-border cooperation and a European network to fight against food fraud was created.[3] But the EU must go further and actions be systematized.

Agro-criminality is a polymorphous and discreet phenomenon. In recent years, Europol, Interpol and a large number of countries have been carrying out operations under the code name Opson in order to dismantle criminal networks.

According to the 2018 report, more than 9.7 million liters of beverages and 3,620 tons of counterfeit food products were seized in 67 countries in four months[4]. The specificity of food fraud is that the consumer is a victim, unlike someone who knowingly buys a fake handbag. In the agribusiness sector, fraud is much more dispersed, more discreet than a drug cartel.

For instance, when a small business faces raw materials issues, it decides to buy somewhere else, cheaper, “just once”. A trader who is willing to release a larger margin provides, without saying it, horse meat instead of beef. In most of cases, it is far from being a real organized crime. Most affected products are those with high margins such as wine, spices, meat or fish. In practice, you take a product out of the trash and make it appear more attractive and put it back on the market, or you lower the cost of the raw material by substituting it for something cheaper.

For instance, honey can be falsified with sugar syrup, olive oil can be cut with oils of lesser quality. Tuna or salmon is soaked in acid to hide their bad taste, and then in chemicals to give them a beautiful color. In this case, it is a food labelling fraud, just like alteration of the “use by” date. This may just result in a lower quality product but it can also, in some cases, prove to be a serious threat for public health.

At the moment, it is up to Member states to decide whether an infringement of EU food rules is considered to be fraud and should be sentenced. In France, the Hamon law has revised the sanctions upwards, increasing the fines up to 10% of the annual average turnover of the fraudulent company. The EU could improve the fight against food fraud by giving a European definition of what is a food fraud, and especially harmonize criminal sanctions in the European Union and make them much more dissuasive.


[1] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety OJ L 31, 1.2.2002, p. 1–24

[2] Regulation (EC) No 178/2002, Article 17 and following

[3] https://ec.europa.eu/food/safety/food-fraud/ffn_en

[4] https://www.europol.europa.eu/operations/opson

Keller and Heckman LLP’s EU Office is Ranked Band 1 in the 2019 Chambers and Partners Europe Guide in the category of Regulatory: Agro/Food Europe-wide. Additionally, Katia Merten-Lentz continues to attain the prestigious individual band ranking. She is one of only four lawyers to receive this prestigious position in this category.

Along with their inclusion in the Chambers Europe Guide, Keller and Heckman’s international Food and Drug practice garners rankings in the Chambers USA Guide, as well as the Chambers Asia-Pacific Guide. These rankings further assert Keller and Heckman’s international stronghold as a leader in the food, drug and packaging law industries.

Keller and Heckman is very grateful to the clients and industries they serve and understands this significant recognition would not be attainable without their support and loyalty.

What are the legal pathways that creators of innovative new protein foods need to tread in Europe?

On February 25, the European Commission published a study on new opportunities for the EU plant protein market, write Katia Merten-Lentz and Thais Payan of international law firm Keller & Heckman. The study concluded that the increased consumer demand for organic and genetically modified (GM)-free supply chains, combined with a rise in the number of flexitarian, vegetarian and vegan diets, will expand markets for pulses and processed proteins.

Indeed, the world-wide demand for new and alternative proteins is driven by both the increased awareness of the negative health impact of high animal protein intake, and the environmental footprint of traditional meat production in combination with the fast-growing world population. However, the development of new products depends very much on the opportunities offered by the legal framework. Many traditional plant-based proteins are used as substitutes for meat, milk and egg. More recently, seaweeds, algae and microalgae have also been added to the range of vegetable food proteins. As the production and sourcing of plant proteins for the agri-food sector has repeatedly stimulated political debate at EU level, the European Commission recently explored how to harness the potential of EU protein plant production, responding to the needs of farmers, producers and consumers.

Other innovative food products can also be ‘new’ source of proteins, such as insects. They are traditionally recognized as normal part of the daily diet throughout the world but are quite new in the European Union. Furthermore, a new development is the introduction of ‘in vitro meat’ – meat produced by in vitro growth of animal cells. Those products are covered by the current legislation, but the EU should further clarify rules applying to new alternative proteins.

From unsafe presumption to the authorization of novel foods

New proteins might be considered as unsafe. Furthermore, since 1997 every ‘novel’ food must be specifically authorized before being placed on the European market.  To be regarded as “novel” a food or food ingredient must not have been used for human consumption to a significant degree within the EU before 15 May 1997 and must belong to one of the categories listed in the Regulation.

This list has been updated by Regulation (EU) 2015/2283. This new regulation also provides a centralized procedure and ends a number of uncertainties for food business operators willing to place new products on the EU market. It has applied since January 2018.

Beyond novelty, food business operators must be aware that the processes they use do not only lead to a “novel food” if it causes modifications of the molecular structure of the food. For instance, even if proteins have been extracted from numerous plants in the EU prior to 1997, some extraction processes may have not been used in the EU prior to 1997, which can make the extracted protein a novel food under the EU regulation.

In addition, the new phrasing provided by Regulation (EU) 2015/2283 explicitly includes dead insects, parts of them and processed insects. The Commission recently reported that since 1 January 2018 there have been a total of 25 applications for insects. Once they have been through the risk assessment process, performed by the EFSA and the European Commission, novel food might be granted a generic authorization and be marketed all around the EU.

Updating existing safety requirements

Even though they would be authorized as novel foods, new products might face others regulatory obstacles before being placed on the market.

On January 23, the European Commission decided that specific requirements are needed for food derived from insects. In order to ensure smooth functioning of the internal market, it submitted (for comments) a proposal for the processing of insects intended for human consumption. The draft regulation also clarifies the connection between the general food hygiene legislation and novel food authorization procedures. It provides that insect food operators active in processing activities shall be subject to approval by their national competent authorities1.

Since the ECJ issued its opinion on the definition of technics of genetic modification, plant-based proteins obtained from new directed mutagenesis technics, such as CRISPR, are considered as GMO. As a consequence, they do not fall under the Novel food Regulation but must comply with all the constraining requirements provided by the GMO legislation. However, the European Commission is to start reviewing the current legislation on this issue by the end of the year.

Finally, the labelling of some of the alternative proteins is under discussion at European level, since the European Commission decided to register a European Citizens’ Initiative entitled ‘Mandatory food labelling Non-Vegetarian / Vegetarian / Vegan’. Beyond general principles and information fairness, in order not to mislead the consumers, new proteins’ labelling could therefore be specifically regulated soon.

Food safety and legal certainty are key challenges for both the food industry and public institutions, but also for the final consumer. The recent development of new products raised challenging safety concerns for public bodies, which intend to follow the way forward by regulating their marketing.

However, as the European Commissioner Hogan recently said: “Good food means good business” and by identifying relevant opportunities offered by the law, food business operators are enabled to supply better food to the consumer, and more in line with new food trends.

This article was first published by EU Food Law on March 1, 2019.

Updated regulations are simplifying the authorization process for traditional foods entering European markets from non-member state countries. In their article, “Nouveaux aliments des pays tiers : un premier bilan encourageant”, which appeared in Les Marchés on January 25, 2019, Katia Merten-Lentz and Caroline Commandeur discuss the new regulations and their potential impact on the food market moving forward. To read the full article, click here.

Written by Katia Merten-Lentz and Oliver Hartmann

At the beginning of this year, the Directorate General for Health and Food Safety of the  European Commission (DG SANTE) published its findings in relation to the Fitness Check of the General Food Law Regulation (EC) No 178/2000  (GFL Regulation), which had been concluded by the end of 2017. Here, Katia Merten-Lentz and Oliver Hartmann at international law firm, Keller and Heckman, look at this check-up found shortcomings in transparency.

As the foundation of the EU’s food law, the GFL Regulation covers the entire food chain, notably all stages of production, processing and distribution of food and feed, including import – also known as the ‘farm to fork’ approach.

It contains general principles of food law, including the principle of risk analysis, making a distinction between risk assessment, risk management and risk communication and the precautionary principle, and general requirements of food law, such as food safety and traceability. Of course, the GFL Regulation also provides for the establishment of the European Food Safety Authority (EFSA).

The Fitness Check of the Regulation was conducted to evaluate whether the established general principles and requirements are appropriate for the purpose by identifying excessive regulatory burdens, overlaps, gaps, inconsistencies and/or obsolete measures.

In general, the REFIT evaluation found that the GFL Regulation remains relevant and has succeeded in achieving a high level of protection of human health and consumers’ interests in relation to food, while contributing to the effective functioning of the internal market.

However, certain shortcomings were identified.

One of the main findings regarding these shortcomings was the increased negative perception by the civil society of EFSA and its risk assessment process of regulated substances – such as, for example, enzymes, additives, pesticides or flavourings – based on studies financed by the industry. In particular, the findings emphasized in this regard that:

“[…]EFSA is bound by strict confidentiality rules that are laid down in the GFL Regulation and in the multiple authorisation procedures in EU secondary food legislation. The application of the confidentiality rules creates the perception of a certain lack of transparency. This perception is further reinforced by the civil society’s concerns over EFSA’s independence from industrial interests, as EFSA bases its risk assessment on authorisation dossiers on studies conducted by the industry. These criticisms in turn can have a negative impact on the acceptability of EFSA’s scientific work by the general public. There is therefore a need to address perceived issues with respect to the transparency as well as the reliability and independence of studies underpinning EFSA’s assessments […].”

Taking these findings into account, the Commission launched at the end of December 2017 the roadmap initiative “Transparency and sustainability of the EU risk assessment model in the food chain” .

A main objective of the initiative is to clarify and improve the transparency of the scientific studies supporting the risk assessment of substances subject to pre-market approval carried out by EFSA.

“One of the main findings was the increased negative perception by the civil society of EFSA and its risk assessment process of regulated substances based on studies financed by the industry”

By way of background, the GFL Regulation subjects EFSA to comprehensive transparency obligations, since its adoption in 2002, per Article 38.

As part of these obligations, EFSA is required to publish, inter alia, agendas, minutes and opinions of the Scientific Committee and Scientific Panels, the information on which its opinions are based, the results of its scientific studies as well as the annual declarations of interest of certain individuals from its staff.

Hence, “a high level of transparency” as formulated in Article 38 of the GFL Regulation is already being implemented in EFSA’s activities.

EFSA’s transparency obligation must be read in conjunction with Article 39 that lays down rules on confidentiality constituting a derogation from Article 38.  In accordance with Article 39, EFSA may not disclose information, that was received and for which confidential treatment has been requested, to third parties.

This general provision of the GFL Regulation is complemented by confidentiality rules set out in sectoral EU food legislation such as Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. Of further relevance, Regulation (EC) No 1049/2001 regulates the right of access by the public to documents of the EU institutions and agencies, like EFSA.

On 11 April, the roadmap initiative resulted in the publication of the Commission’s legislative proposal on the transparency and sustainability of the EU risk assessment model in the food chain , amending principally the GFL Regulation and introducing, amongst other things, significant changes to rules on transparency and confidentiality under Articles 38 and 39. Besides the changes to the GFL Regulation, the Commission proposal amends, at the same time, relevant provisions of sectoral EU food legislation pertaining to GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes, flavourings, plant protection products and novel foods.

In particular, the proposal amends Article 38 by extending EFSA’s transparency obligations specifically to scientific data, studies and other information supporting applications for authorization of substances regulated under EU food law, including supplementary information supplied by applicants.

On this basis, EFSA is required to disclose scientific studies generated by the industry for the risk assessment of regulated substances. However, it is important that the obligation by EFSA to disclose such information does not affect any existing intellectual property rights and data exclusivity provisions established in sectoral food legislation. In addition, certain information may be protected as confidential in line with Article 39 as revised by the proposal.

Of relevance, the amended Article 39 restricts confidential treatment in principle to the following four types of information:

  • the method and other technical and industrial specifications relating to the method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion;
  • commercial links between a producer or importer and the applicant or the authorisation holder, if applicable;
  • commercial information revealing sourcing, market shares or business strategy of the applicant;
  • quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.

When requesting confidential treatment of such information positively identified in the revised provision of Article 39, the respective applicant must still provide verifiable justification that disclosure significantly harms its (commercial) interests.

This approach adopted by the Commission could have repercussions for the promotion of innovation and stimulating research and development within the agri-food sector.

Interestingly, the amended Article 39 envisages that information may still be made publicly available, even if it is considered confidential, under the condition that urgent action is essential to protect public health, animal health or the environment, or that such information is part of the conclusions of EFSA opinions and relates to foreseeable health effects. In other terms, an overriding provision has been incorporated allowing for EFSA to disclose confidential information under certain circumstances.

Another novelty introduced by the proposal is that if an applicant requests confidentiality for certain parts of a scientific study generated, the applicant must submit a confidential and non-confidential version of the study concerned to EFSA. The Authority then publishes the non-confidential version of submitted study, while it will assess and decide on the confidentiality request for the identified information.

The proposal determines that the publication of the non-confidential version of the scientific study and the assessment of the confidentiality request must be conducted without delay by EFSA.

If EFSA takes the view that the confidentiality request cannot be supported, EFSA is obliged to inform the applicant of its intention to disclose the information and the reasons prior to taking the formal decision.

Following the notification of EFSA’s position, the applicant has the opportunity to state its views or withdraw the application. The next stage of this procedure, EFSA must adopt a reasoned decision on the confidentiality request taking into account the views of the applicant, where submitted within ten weeks from the date of receipt of the confidentiality request.

Consequently, any information for which the confidentiality request is considered not justified, would be made public, unless the corresponding application was withdrawn by the applicant before the decision on the confidentiality request by EFSA.

Openness of scientific studies

The tabled proposal demonstrates the Commission’s willingness to ensure that most of the content of the scientific studies provided by the industry for the risk assessment process are made public.

While intellectual property rights and data exclusivity provisions established in sectoral food legislation are still protected, the grounds for confidential treatment of information are narrowly defined so that the proposal restricts the possibility significant for the industry to keep information and data included in scientific studies confidential.

This approach adopted by the Commission could have repercussions for the promotion of innovation and stimulating research and development within the agri-food sector. More specifically, the extension of transparency and the restriction of confidentiality facilitates the publication of data submitted for the risk assessment of a regulated substance that could allow competitors of the given applicant to potentially use, one way or another, the generated data for the substance concerned without having to face the same costs and efforts.

In terms of next steps, the Commission proposal is submitted to the Council and the Parliament for review taking into account that the two EU institutions as co-legislators may table amendments to the proposal. It, therefore, remains to be seen to what extent the initial provisions of the proposal are kept.

 

This article was first published by EU Food Law on April 19, 2018.

Katia Merten-Lentz provided her expertise on plant-based meat and cultured-meat for the recently published research paper Meat Analogues: Considerations for the EU. The paper was published by Chatham House, The Royal Institute of International Affairs, which is a world-leading policy institute based in London whose mission is to help governments and societies build a sustainably secure, prosperous and just world.

Keller and Heckman’s Food and Drug practice continues to monitor the developing plant-based meat and cultured-meat industry. Late last year Katia Merten-Lentz published “In vitro meat: regulatory issues in the US and the EU” for EU Food Law. In addition, Keller and Heckman’s The Daily Intake Blog has published multiple articles on the topic.

Keller and Heckman food law attorney Katia Merten-Lentz was interviewed for the Le Monde article (in French) “Des insectes dans notre assiette, en toute légalité?” which reported on the recent European Commission decision on insect-based food for human consumption confirming that prior authorization is required. Keller and Heckman’s Food and Drug Practice has been monitoring this topic, for a brief history of the legislation (in English) click here and for a succinct summary of the legislation (in English) click here.

With ongoing European efforts to update the General Food Law and increase transparency in the risk assessment process for food products, Katia Merten-Lentz, a legal expert with international law firm Keller and Heckman, discusses the current state of play and looks to the future of food regulation in the EU.

The EU Regulation 178/2002, known as the General food law (the GFL), is the cornerstone of European food law, but also of the free movement of food throughout the European Union.

The general principles of food safety set out therein form the horizontal general framework that applies to the entire food production chain, from farm to fork. Even though the GFL is largely supplemented by sectoral regulation, it provides for key principles such as:  all rules applicable to foodstuffs must be based on a risk assessment.

The GFL has been adopted following the 90’s food crisis. More than 20 years after the entry into force of this text, the Commission launched, in 2014, a “regulatory fitness and performance program” (so-called REFIT) to analyze its relevance and effectiveness, to be possibly followed by a reform.

EU REFIT and report

On January 15th 2018, the Commission reported positive results regarding the relevance of the provisions[1].

However, the Commission highlighted a number of inconsistencies in the application of the regulation, such as different national interpretations, and the variation in the level of penalties imposed by the national authorities. This remains a factor of legal uncertainty for food business operators.

The Commission also identified a need of simplification of food labeling rules. In particular, the Commission pointed out the slow pace of authorization procedures concerning additives, novel foods, health claims or additives for animal feed. This hinders the smooth market entry of innovative food products,  and in doing so, hinders innovation itself.

In parallel, the Commission raised another important issue regarding the transparency in risk assessment. In the Commission’s view, the possibility of strengthening the transparency, reliability and independence of studies underpinning EFSA’s assessments, while protecting legitimate confidential business information, should be further explored.

Targeted reform proposal submitted by the European Commission

As a next step, the Commission launched a targeted revision of the GFL with the aim to reinforce the  confidence of Europe’s citizens in the EFSA application process, notably with to sensitives issues, such as GMO or food additives. In this respect, the Commission published a roadmap[2] followed by a Proposal for a Regulation on the transparency and sustainability of the EU risk assessment in the food chain[3].

The Proposal suggests a significant budget increase for EFSA but at the same time recommends to strengthen transparency and risk communication to citizens. Indeed, in several occasions, there have been divergences between Union and national risk assessors, which had a negative impact on public perception. Therefore, the Proposal calls for a promotion of public awareness and better explanation of scientific opinions to citizen.

On 11 December 2018, the European Parliament discussed the initial Proposal and adopted amendments as MEPs called for a more “science-based approach”. The MEP debate was in particular driven by intense discussions relating to transparency and divisions ran on the relation between industry’s competitiveness and the appropriate level of transparency for citizens.

Following the December discussion’s, MEPs finally decided that studies should be made available to the public during the risk analysis rather than at the time application or when the opinion is delivered, and they agreed on which criteria should be applied for deciding what information may be considered confidential.

The day after, on 12 December 2018, the Committee of Permanent representatives (Coreper) agreed on the Council position, paving the way for starting the trilogies. A provisional agreement should be issued by the end of February. Obviously, the decision process is closely followed by the food industry, whose interests are highly involved.

This week, the Parliament and Council approved the Commission’s proposed ESFA reforms in the conclusion of trialogue discussions. The provisional agreement will now have to formally be adopted both the European Parliament and the Council.

This article was first published in FOODnavigator.com on February 14, 2019.

[1] https://ec.europa.eu/food/sites/food/files/gfl_fitc_executive_summary_2018_en.pdf

[2] https://ec.europa.eu/info/law/better-regulation/initiative/1519/publication/151777/attachment/090166e5b7579aa2_en

[3] COM (2018) 179: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavorings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorization procedure for food additives, food enzymes and food flavorings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods], COM/2018/0179 final – 2018/088 (COD) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:179:FIN