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Where does laboratory produced meat fit in the regulatory frameworks of the US and the European Union?

Meat produced in a laboratory is close to coming to market, raising questions about the regulatory hurdles the US and EU may put in place

Published 11 Dec 2018 at EU Food Law

ANALYSIS

On 16th November 2018, the US Department of Agriculture and the US Food and Drug Administration announced that they had reached an agreement on a joint regulatory framework on laboratory made, cultured meat, also called in vitro meat. The Agencies have not yet revealed which framework will apply to this new way of making meat, but their respective roles have been clarified, as Katia Merten-Lentz of international law firm, Keller & Heckman, reports.

Cultured meat, or in vitro meat, is a form of cellular agriculture allowing the growth of meat from animal cells. Over the last few years, the price of producing this meat has dropped drastically, raising the possibility of these meats hitting the market.

However, these developments have also raised questions about their regulatory status, safety and labelling issues.

The statement released by the USDA and the FDA in November is another step towards the setting up of a regulatory framework regarding in vitro meat. The agencies have decided to oversee jointly the production of in vitro meat , according to their regular competencies: the FDA will oversee the first stages regarding cell-culture technology, and USDA the production and labelling of in vitro-meat. The joint statement of USDA and FDA does not explain which regulatory status will be applied to lab meat. But this status – as well as labelling issues – will have to be settled before the meat is placed on the market.

 

Regulatory status and safety assessment of meat in vitro

The US and EU regulatory framework regarding meat in vitro will differ.Regarding the US, several hypotheses can be explored. The first important hurdle is that it is arguably difficult to consider that in vitro meat fits in the definition of “meat product” as defined in the Federal Meat Inspection Act (FMIA), since FMIA assumes a meat food product is derived from a carcass.

If FMIA is inapplicable to culture meat, the rules regarding conventional foods would probably apply, and the FDA’s Biotechnology Policy could provide some help  in analysing the status of cultured meat.

It is also possible that in vitro meat could be considered to be a food additive.

The current method for growing in vitro meat consists of using a cell culture medium or scaffold, which is a structure where the cells attach to in order to allow growth, and cellular growth factors.

As explained by the Food and Drug Law Institute , the FDA may consider that these substances are food additives, since they are intentionally added to a food.

If it is the case, they will have to be authorised, unless they meet the two so called GRAS criteria (generally recognized as safe) i.e.: there is a reasonable certainty of no harm; and the intended use of the substance in food must be recognised as safe by qualified experts based on publicly available scientific information (general recognition standard).

Moreover, the safety of the primary cells used would also have to be asserted, since they are genetically modified cell lines. This may pose a hurdle, as, according to the US Consumers Union, “these lines exhibit the characteristics of a cancerous cell”.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

Indeed, in vitro meat falls under a relevant category in the Novel Foods Regulation that explicitly refers to food produced from cell culture or tissue culture derived from animals.

In its answer to a parliamentary question on this topic in October, the European Commission confirmed that in vitro meat may fall in this category and must then be considered as a novel food.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

For being authorised as a novel food, the producers of in vitro meat will have to file an application which must include all relevant data.If the product is deemed safe after a scientific assessment by the European Food Safety Authority (EFSA), the Commission can enact a Regulation to authorise in vitro meat.  The Commission recently confirmed that no application for the authorisation of in vitro meat has been received so far.

Therefore, in vitro meat cannot yet be placed on the market, and any such meat would be seized by the authorities.

This is what happened in December 2017, when tasting experiments of cultured meat made by the company JUST were organized in the Netherlands, and the Dutch Safety Authority sealed the products to prevent them from being consumed.

Issues regarding labelling

The Novel Foods Regulation states that when novel foods are added to the Union list of authorized novel food, there can be requirements regarding labelling, in order to fully inform the consumer, for instance by describing the food or its composition. It is more than likely that specifications will be added for in vitro meat.

In any case the EU Regulation on Food Information to Consumers (also known as ‘the FIC Regulation’) will apply to in vitro meat once it is authorised, but its application may prove challenging.

For instance, there is an obligation to indicate on the label the denomination of a food, but there are unsolved issues regarding the denomination of in vitro meat.

Since this food is not on the market yet, there is no legal name and no customary name either. Many names already coexist (in vitro meat, cultured meat, clean meat, lab meat, etc.), and the choice of the name is quite touchy.

Since the FIC Regulation’s main objective is to ensure that fair, clear and precise information is provided to the consumers – for instance about the manufacturing or production method – it seems very likely that operators will have to ensure that the product name makes clear that the meat has been grown in a lab.

Moreover, in vitro meat does not comply with the current European definition of “meat”. According to the FIC Regulation, the definition of meat – for labelling purpose – is: ‘skeletal muscles of mammalian and bird species recognised as fit for human consumption with naturally included or adherent tissue (…)’.  In vitro meat neither consists of “skeletal muscles” (‘muscles under the voluntary control of the somatic nervous system’) nor of ‘naturally’ included or adherent tissues, so it would mean that the term ‘meat’ could not be used in the current state of the EU legislation.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

The exact same issue applies for the US as in vitro meat does not comply exactly with the definition of “meat food product” under FMIA. In the EU, there are also specific issues regarding the labelling of meat that will be difficult to apply to in vitro meat.

Several regulations make the indication of the country of origin or place of provenance of meat mandatory.  However, for in vitro meat, since there is no animal being born, reared or slaughtered, it will be virtually impossible to apply this disposition.

In the US, the public is given the opportunity to comment on the regulatory issues regarding lab meat until 26 December 2018. The expected statements that will follow from the public agencies will hopefully reveal for operators the first outlines for a regulatory framework for in vitro meat.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

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Food companies fail to agree on new nutrition label in Europe

Trials to highlight calories, fat, sugar and salt to be abandoned after two years

© The Financial Times Limited 2018

Five of the world’s biggest food companies have abandoned trials aimed at developing a new nutrition labelling scheme for Europe, dealing a blow to efforts to help consumers better understand what is in their food.

Coca-Cola, Mondelez, Nestlé, PepsiCo and Unilever have been working together for two years on an “Evolved Nutrition Label”, which would have replaced the monochrome labelling system in place in Europe.

The new label sought to use colours from red to green to indicate whether a portion of a given food was high in calories, fat, sugar or salt.

But after trials in several countries and consultation with academics and consumer groups, the companies could not gain consensus around the new portion-based, colour-based scheme, said Bart Vandewaetere, a Nestlé government affairs executive. […]

 

Click here to read full article and Katia’s expert opinion.

Photo of Katia Merten-Lentz

This article was originally printed in EU Food Law.

The current provisions of the Food Information to Consumers Regulation No. 1169/2011 exempt alcoholic beverages containing more than 1,2 % by volume of alcohol from the mandatory labelling requirement to provide an ingredients list and a nutrition declaration, writes Katia Merten-Lentz of international law firm Keller and Heckman.

Food operators can include such information on alcoholic beverages containing more than 1,2 % by volume of alcohol on a voluntary basis.

Article 30 (4) of the Food Information to Consumers (FIC) Regulation allows a limit on the nutrition declaration to just the energy value on alcoholic beverages if it is provided voluntarily.

This represents another example of preferential treatment for alcoholic beverages under the FIC Regulation, taking into account that the nutrition declaration should generally be fully provided, even if the nutritional declaration is provided voluntarily.

For instance, if the nutrition declaration is given voluntarily on foods that are exempted from the requirement of the mandatory nutrition declaration under the FIC Regulation, like for example chewing gums, the nutrition declaration must provide the energy value, but also the amounts of fat, saturates, carbohydrate, sugars, protein, and salt.

Furthermore, Article 34 (4) of the FIC Regulation exempts alcoholic beverages from the general requirement to provide the nutrition declaration in a tabular format. Based on this provision, alcoholic beverages can provide the nutrition declaration in a different format other than the tabular format.

Although the FIC Regulation exempts alcoholic beverages from the requirement to provide an ingredients list on the label, it explicitly allows Member States to maintain national measures with regard to the provision of an ingredients list on alcoholic beverages.

In several Member States, these national measures exist in order to regulate the labelling of ingredients for alcoholic beverages, as in Germany, where pre-packaged beer must be labeled with a list of ingredients.

The Commission Report

Despite the specific exemptions for alcoholic beverages incorporated in the FIC Regulation, the Commission had the obligation to produce a report on whether alcoholic beverages should be covered in the future by the mandatory labelling requirement to provide the ingredients list and nutrition declaration. The report must also include reasons justifying possible exemptions.

On 13 March 2017, the Commission published the report. The Report states that: “On the basis of the information reviewed, the Commission has not identified objective grounds that would justify the absence of information on ingredients and nutrition information on alcoholic beverages or a differentiated treatment for some alcoholic beverages, such as ‘alcopops’.”

In other words, the Commission essentially concluded that alcoholic beverages should comply with the same labelling requirements as other food products and, therefore, they should indicate on their labels an ingredients list and a nutrition declaration.

“If the Commission considers the (industry) proposal to be insufficient or unsatisfactory, it will launch an impact assessment on possible regulatory and non-regulatory options regarding the labeling of alcoholic beverages”

The Commission then requested the alcohol industry to present a self-regulatory proposal covering the entire sector of alcoholic beverages in view of consumer expectations.

One year later, on 12 March 2018, the requested self-regulatory proposal was submitted by the alcohol industry to the Commission. The presented proposal consists of a common part applicable to the whole alcoholic beverages industry, complemented by four annexes detailing how the general commitments are implemented for each respective industry sector, i.e., beer, spirits, wine and aromatized wine, cider and fruit wine.

In general, the industry commits that “[t]he nutrition information and the list of ingredients of our products will be provided to consumers off-label and/or on label where information provided off-label will be easily accessible from the label itself, either by a web-link, a QR code, a barcode or through other direct means using smart technologies.”

On this basis, the alcohol industry envisages a dual, flexible approach based on which the nutritional information and the ingredients lists may either be provided on the label or online, depending on the discretion of the individual business operator.

The proposal also specifies that the nutrition declaration can be limited to the energy value with reference to Article 30 (4) of the FIC Regulation and may be presented in a format other than the tabular format based on Article 34 (4) of the FIC Regulation. In this context, certain sectors – such as the wine and aromatized wine sector – intend to use symbols, like ‘E’ for energy, for the nutrition declaration.

A specific position is taken by the Spirits Industry in the corresponding sectorial annex to the common proposal in relation to the expression of the nutritional values, like the energy value, per 100 ml as required under the FIC Regulation.

In detail, the Spirits Industry considers that the indication per 100 ml would be misleading for consumers as spirits are never served in 100 ml portions and would go against messages on responsible drinking. The Spirits Sector argues, therefore, that nutritional values for spirits should be rather given per serving size.

The Commission is currently assessing the proposal received from the alcohol industry. If the Commission considers the proposal to be insufficient or unsatisfactory, it will launch an impact assessment on possible regulatory and non-regulatory options regarding the labeling of alcoholic beverages.

Industry proposal criticised

Indeed, certain aspects of the proposal must be questioned with regard to their compliance with the standards established by the FIC Regulation. Principally, the approach to provide the ingredients list and the nutritional information off-pack, i.e., online, is not covered by provisions of the FIC Regulation.

These rules determine that mandatory labelling particulars, including the ingredients list and the nutrition declaration, must be easily accessible for the consumer and must, therefore, directly appear on the package. Certainly, the suggestion of the spirits sector to provide nutritional values per portion size for spirits is not in line with the general obligation under the FIC Regulation to provide such values per 100 g or 100 ml.

At the same time, many other foods that are also not consumed in portions of 100 g or 100 ml are compelled to comply with the general requirement to express nutritional values per 100 g or 100 ml.

Against this background and in view of the conclusion by the European Commission in its report that the absence of the ingredients list and the nutrition declaration on alcoholic beverages cannot be justified by any means, it is doubtful that the Commission would accept the presented self-regulatory proposal by the alcohol industry that essentially prolongs the current exemption of alcoholic beverages from providing the ingredients list and the nutrition declaration on the packaging.

Labeling of Alcoholic Beverages in the EU: The Existing Regulatory Framework under Regulation 1169/2011 and the Self-Regulatory Proposal Presented by Industry

The current provisions of the EU Labeling Regulation No. 1169/2011 exempt alcoholic beverages containing more than 1,2 % by volume of alcohol from the mandatory labeling requirement to provide an ingredients list and a nutrition declaration. Food operators may include such information on alcoholic beverages containing more than 1,2 % by volume of alcohol on a voluntary basis.

More specifically, the EU Labeling Regulation attempts to encourage business operators to provide on a voluntary basis the information contained in the nutrition declaration of foods, for example, alcoholic beverages. In this respect, Article 30 (4) of the EU Labeling Regulation allows limiting the nutrition declaration to only the indication of the energy value on alcoholic beverages, if it is provided voluntarily. This represents another example of preferential treatment for alcoholic beverages under the EU Labeling Regulation, taking into account that the nutrition declaration should generally be fully provided, even if the nutritional declaration is provided voluntarily. For instance, if the nutrition declaration is given voluntarily on foods that are exempted from the requirement of the mandatory nutrition declaration under the EU Labeling Regulation, like for example chewing gums, the nutrition declaration must provide the energy value, but also the amounts of fat, saturates, carbohydrate, sugars, protein, and salt. Furthermore, Article 34 (4) of the EU Labeling Regulation grants for a specific exemption to alcoholic beverages from the general requirement to provide the nutrition declaration in a tabular format. Based on this provision, alcoholic beverages can provide the nutrition declaration in a different format than the tabular format.

Although the EU Labeling Regulation exempts alcoholic beverages from the requirement to provide an ingredients list on the label, it explicitly allows Member States to maintain national measures with regard to the provision of an ingredients list on alcoholic beverages. In several Member States, such national measures exist regulating the labeling of ingredients for alcoholic beverages, as in Germany, where pre-packaged beer must be labelled with a list of ingredients[1].

Despite the specific exemptions for alcoholic beverages incorporated in the EU Labeling Regulation, the Commission has the obligation to produce a report on whether alcoholic beverages should be covered in the future by the mandatory labeling requirement to provide the ingredients list and nutrition declaration. The report must also include reasons justifying possible exemptions, suggested that the exemptions may only be of tentative nature.

On 13 March 2017, the Commission published this report as required under the EU Labeling Regulation regarding to the mandatory labeling of the list of ingredients and the nutrition declaration of alcoholic beverages[2]. The Report states that: “On the basis of the information reviewed, the Commission has not identified objective grounds that would justify the absence of information on ingredients and nutrition information on alcoholic beverages or a differentiated treatment for some alcoholic beverages, such as ‘alcopops’.” In other terms, the Commission essentially concluded that alcoholic beverages should comply to the same labeling requirements as other food products and, therefore, they should indicate on their labels an ingredients list and a nutrition declaration.

As a result of/Following its findings, the Commission requested the alcohol industry to present a self-regulatory proposal covering the entire sector of alcoholic beverages in view of consumer expectations.

One year later, on 12 March 2018, the requested self-regulatory proposal was submitted by the alcohol industry to the Commission. The presented proposal[3] consists of a common part applicable to the whole industry of alcoholic beverages, complemented by four annexes detailing how the general commitments are implemented for each respective industry sector, i.e., beer, spirits, wine and aromatized wine, cider and fruit wine. In general, the industry commits that “[t]he nutrition information and the list of ingredients of our products will be provided to consumers off-label and/or on label where information provided off-label will be easily accessible from the label itself, either by a web-link, a QR code, a barcode or through other direct means using smart technologies.”

On this basis, the alcohol industry envisages a dual, flexible approach based on which the nutritional information and the ingredients lists may either be provided on the label or online, depending on the discretion of the individual business operator. The proposal also specifies that the nutrition declaration can be limited to the energy value with reference to Article 30 (4) of the EU Labeling Regulation and may be presented in a format other than the tabular format based on Article 34 (4) of the EU Labeling Regulation. In this context, certain sectors – such as the wine and aromatized wine sector – intend to use symbols, like ‘E’ for energy, for the nutrition declaration.

A specific position is taken by the Spirits Industry in the corresponding sectorial annex to the common proposal in relation to the expression of the nutritional values, like the energy value, per 100 ml as required under the EU Labeling Regulation. In detail, the Spirits Industry considers that the indication per 100 ml would be misleading for consumers as spirits are never served in 100 ml portions and would go against messages on responsible drinking. The Spirits Sector argues, therefore, that nutritional values for spirits should be rather given per serving size.

The Commission is currently assessing the proposal received from the alcohol industry. If the Commission considers the proposal to be not sufficient or unsatisfactory, it will launch an impact assessment on possible regulatory and non-regulatory options regarding the labeling of alcoholic beverages. In the meantime, Member States seem to have taken a clear position on the industry proposal. Following the meeting of the Standing Committee on Plants, Animals, Food and Feed on 16 April, which discussed the self-regulatory proposal of the alcohol industry, several Member States criticized that the proposal is not in conformity with the EU Labeling Regulation.

Indeed, certain aspects of the proposal must be questioned with regard to their compliance with the standards established by the EU Labeling Regulation. Principally, the approach to provide the ingredients list and the nutritional information off-pack, i.e., online, is not covered by provisions of the EU Labeling Regulation. These rules determine that mandatory labeling particulars, including the ingredients list and the nutrition declaration, must be easily accessible for the consumer and must, therefore, directly appear on the package. Certainly, the suggestion of the spirits sector to provide nutritional values per portion size for spirits is not in line with the general obligation under the EU Labeling Regulation to provide such values per 100 g or 100 ml. At the same time, many other foods that are also not consumed in portions of 100 g or 100 ml are compelled to comply with the general requirement to express nutritional values per 100 g or 100 ml.

Against this background and in view of the conclusion by the Commission in its report that the absence of the ingredients list and the nutrition declaration on alcoholic beverages cannot be justified by any means, it is doubtful that the Commission would accept the presented self-regulatory proposal by the alcohol industry that essentially prolongs the current exemption of alcoholic beverages from providing the ingredients list and the nutrition declaration on the packaging.

 


[1] See German Ordinance ‘Verordnung zur Durchführung unionsrechtlicher Vorschriften betreffend die Information der Verbraucher über Lebensmittel  (Lebensmittelinformations-Durchführungsverordnung – LMIDV)’.

[2] Report from the Commission to the European Parliament and the Council regarding the regarding the mandatory labeling of the list of ingredients and the nutrition declaration of alcoholic beverages, COM(2017) 58 final.

[3] Joint self-regulatory proposal from the European alcoholic beverages sectors on the provision of nutrition and ingredients listing (guiding principles) with sector specific Annexes by the following European associations representing the alcoholic beverages sector: CEEV, EFOW, CopaCogeca, CEVI, SpiritsEurope, The Brewers of Europe and AICV.