Notifizierungsangaben | TRIS - European Commission

Bestimmungen über das Verbot der Erzeugung und Vermarktung von Lebens- und Futtermitteln, die aus Zellkulturen oder Geweben von Wirbeltieren bestehen, aus ihnen isoliert oder daraus gewonnen werden, und über das Verbot der Bezeichnung als Fleisch...

Notifizierungsnummer:

2023/0469/IT (Italy)

Eingangsdatum:

27/07/2023

Ende der Stillhaltefrist:

30/10/2023 (withdrawn)

Entwurfsdokument:

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Mitteilung 001

Mitteilung der Kommission - TRIS/(2023) 2260

Richtlinie (EU) 2015/1535

Notifizierung: 2023/0469/IT

Mitteilung eines Entwurfstextes eines Mitgliedstaats

Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt

Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna

MSG: 20232260.DE

1. MSG 001 IND 2023 0469 IT DE 27-07-2023 IT NOTIF

2. Italy

3A. MINISTERO DELLE IMPRESE E DEL MADE IN ITALY
Direzione generale per il mercato,la concorrenza,la tutela del consumatore e la normativa tecnica
Divisione VI-Normativa tecnica-Sicurezza e conformità dei prodotti
+39 64705.2554 ucn98.34.italia@mise.gov.it

3B. MINISTERO DELL'AGRICOLTURA, DELLA SOVRANITÀ ALIMENTARE E DELLE FORESTE
Dipartimento delle politiche competitive, della qualità agroalimentare, della pesca e dell'ippica
Direzione generale per la promozione della qualità agroalimentare e dell'ippica
PQAI I
ROMA

4. 2023/0469/IT - C50A - Lebensmittel

5. Bestimmungen über das Verbot der Erzeugung und Vermarktung von Lebens- und Futtermitteln, die aus Zellkulturen oder Geweben von Wirbeltieren bestehen, aus ihnen isoliert oder daraus gewonnen werden, und über das Verbot der Bezeichnung als Fleisch...

6. Lebens- und Futtermittel, die aus Zellkulturen/verarbeiteten Erzeugnissen, die pflanzliche Proteine enthalten, isoliert oder daraus gewonnen werden

7.

8. Mit dem Entwurf soll ein Verbot der Erzeugung und Vermarktung von Lebens- und Futtermitteln eingeführt werden, die aus Zellkulturen oder Geweben von Wirbeltieren bestehen, aus ihnen isoliert oder daraus gewonnen werden, sowie ein Verbot der Bezeichnung von verarbeiteten Erzeugnissen, die pflanzliche Proteine enthalten, als Fleisch.
Der Text des Entwurfs besteht aus sieben Artikeln.
Der erste Artikel beschreibt die Zwecke und legt die Definitionen fest.
Mit dem zweiten Artikel wird ein Verbot der Erzeugung und Vermarktung von Lebens- und Futtermitteln eingeführt, die aus Zellkulturen oder Geweben von Wirbeltieren bestehen, aus ihnen isoliert oder aus ihnen gewonnen werden.
Mit dem dritten Artikel wird ein Verbot eingeführt, verarbeitete Erzeugnisse, die pflanzliche Proteine enthalten, als Fleisch zu bezeichnen.
Im vierten Artikel sind die für die Durchführung der Kontrollen zuständigen Behörden sowie die detaillierten Vorschriften für die Anwendung von Sanktionen aufgeführt, die in den folgenden Artikeln 5 und 6 weiterentwickelt werden.
Schließlich gibt es einen abschließenden Artikel über die Klausel zur finanziellen Invarianz.

9. Angesichts des Fehlens spezifischer Rechtsvorschriften auf europäischer Ebene wurde beschlossen, auf nationaler Ebene vorsorglich tätig zu werden, um die Interessen in Bezug auf Gesundheit und Kulturerbe zu schützen. Der Gesetzesentwurf zielt insbesondere darauf ab, die menschliche Gesundheit zu schützen, indem ein Verbot der Herstellung und Vermarktung synthetischer Lebensmittel in Anwendung und unter Beachtung des Vorsorgeprinzips gemäß Artikel 7 der Verordnung (EG) Nr. 178/2002 des Europäischen Parlaments und des Rates vom 28. Januar 2002 festgelegt wird.

10. Verweise auf Grundlagentexte:
B-2023-0469-IT-01

11. Nr.

12.

13. Nr.

14. Nein

15. Nein

16.
TBT-Aspekt: Nein

SPS-Aspekt: Nein

**********
Europäische Kommission
Allgemeine Kontaktinformationen Richtlinie (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu

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BEUC response to TRIS Notification on Draft Law 2023/0469/IT

BEUC welcomes the opportunity to provide comments on Italy’s draft law regarding the production and marketing of food and feed consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals, as well as on the provisions related to the designation of processed products containing vegetable proteins as meat.

There is growing awareness among consumers about the detrimental environmental and human health impacts associated with intensive livestock production and consumption. The IPCC highlighted that there is significant potential mitigation (high confidence) arising from the adoption of diets in line with dietary recommendations, typically diets higher in plant-based foods (1).

Most European consumers are willing to change their eating habits for the environment, such as reducing meat consumption. Yet for this to happen, a range of attractive, affordable, and convenient alternative sources of proteins must be available to them. We are concerned that the Italian draft law risks undermining the development of such alternative products.

On Article 2. (Prohibition on the production and marketing of food and feed consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals)

A robust regulatory framework for novel food authorisation is in place in the EU, making it unnecessary to propose a preventive ban on food produced from cell cultures.

Cultivated meat products are not yet authorised in the European Union and as of September 2023, the European Food Safety Agency (EFSA) has not yet received any applications for such products. As a novel food, cell-culture derived meat will need to be evaluated as safe by EFSA and subsequently to be authorised by the European Commission and Member States before it can be sold to consumers. Moreover, the novel food regulation provides that “additional labelling information, in particular regarding the description of the food, its source, its composition or its conditions of intended use to ensure that consumers are sufficiently informed of the nature and safety of the novel food” can be required in the context of a novel food authorisation.

The Italian draft law invokes the precautionary principle to justify the preventive ban on food from cell cultures. Yet the novel food regulatory framework itself is already a manifestation of the application of the precautionary principle, since it requires that newly developed, innovative food or food produced using new technologies and production processes should undergo a thorough safety risk assessment prior to being sold to consumers. A preventive ban on food from cell culture is superfluous, as such food will simply not be authorised in the EU if it is not proven safe.

On Article 3. (Prohibition on the designation of processed products containing vegetable proteins as meat)

A survey of consumers on attitudes to sustainable food BEUC conducted 2019 found that most consumers do not appear to be concerned about the naming of veggie ‘burgers’ or ‘sausages’, as long as the products are clearly identifiable as vegetarian/vegan. On average, only 1 in 5 European consumers (20.4%) think the use of ‘meaty’ names should never be allowed on vegetarian/vegan products. Most respondents (42.4%) believe these names should be permitted provided that the products are clearly labelled as vegetarian/vegan, and 1 in 4 (26.2%) do not see any problem at all with using such names (11% have no opinion).

In Italy, 47% of consumers believe these names should be permitted provided the products are clearly labelled as vegetarian/vegan; 24.3% see no problem with using such names, 15% have no opinion on the matter, and 13% are against it.

As the Farm to Fork Strategy underlines, European consumers need to move to “a more plant-based diet with less red and processed meat”. The attractiveness of alternative protein sources depends on them being easily identifiable by consumers.

Currently, a ruling by the EU Court of Justice is pending which is expected to clarify whether Members States can introduce their own restrictions on the denomination of plant-based products or whether EU-level harmonisation prevents them from doing so. Member States should refrain from introducing new rules in this area until the ruling has been issued.

(1) IPCC, 2019: Climate Change and Land: an IPCC special report on climate change, desertification, land degradation, sustainable land management, food security, and greenhouse gas fluxes in terrestrial ecosystems [P.R. Shukla, J. Skea, E. Calvo Buendia, V. Masson-Delmotte, H.-O. Pörtner, D. C. Roberts, P. Zhai, R. Slade, S. Connors, R. van Diemen, M. Ferrat, E. Haughey, S. Luz, S. Neogi, M. Pathak, J. Petzold, J. Portugal Pereira, P. Vyas, E. Huntley, K. Kissick, M. Belkacemi, J. Malley, (eds.)]. In press.

*Please see attached document for the full references list*

Dear Ministers,

Dear Member State representatives,

On 27 July 2023 the Italian government submitted a TRIS notification to the European Commission for draft law 2023/0469/IT. We, NGO Essere Animali, are writing to you today to express our strong opposition to this bill.

As an animal welfare association advocating for a more sustainable and resilient food system we represent more than 800,000 supporters, activists, and followers on digital and offline communication channels, and we are truly concerned about the provisions against both cultured meat and plant-based alternatives to meat included in this measure, which we deem out of time and far from the demands of consumers and businesses. The bill banning the production and commercialization of cultivated meat for human and animal consumption in Italy is an anti-scientific move that harms the Italian economy, the environment and animals, which will discourage private investors and damage especially small and medium-sized Italian companies. Included in Art. 3 of the bill is also the Prohibition of Meat Designation for Processed Products Containing Vegetable Protein, an off-topic provision from the focus of the bill, as well as in contrast with current market trends and likely to undermine fair competition between EU business operators marketing substitutable products.

Given that food production already accounts for more than a third of climate change causing greenhouse gases, we can not meet this additional demand for animal protein using conventional methods without failing to address our current climate and biodiversity loss crises. As the EU’s flagship Farm to Fork Strategy also underlines, European consumers need to move to “a more plant-based diet with less red and processed meat”. For this to happen, convenient alternative sources of proteins must be made available and easily identifiable to consumers. Alternative proteins like plant-based and cultivated meat emerge as a key solution to mitigate the environmental impact of our food system, decrease the risk of zoonotic disease, and ultimately feed more people with fewer resources.

A huge body of research, including the 2022 IPCC Sixth Assessment Report on Climate Change, acknowledges that emerging food technologies – such as precision fermentation, cultivated meat, and plant-based foods – can promise substantial reductions in direct greenhouse gases emissions from food production. Estimates from a comprehensive Life Cycle Assessment analysis published in January 2023 has confirmed that cultured meat production could decrease land use by 64 to 90 percent, emit 20 to 94 percent less greenhouse gases, cause 69 to 98 percent less soil acidification and 75 to 99 percent less eutrophication than conventional meat production. Research also shows that plant-based alternatives to meat emit 30%–90% less greenhouse gas, use 47%–99% less land and 72%–99% less water, and cause 51%–91% less aquatic nutrient pollution than conventional meat.

Alternative proteins also present a substantive economic opportunity for Italy and all Member States. Global demand for meat is expected to sharply increase by 50% or more by 2050. By focusing on more sustainable farming practices and creating a thriving ecosystem for food innovation, Europe has the opportunity to position itself as a world leader and exporter of alternative protein sources that meet global demand more sustainably. Such prohibitions included in this legislation are very much likely to stifle innovation within industry and academia, and prevent Italy – with wider implications on Europe – from benefiting economically from the growth of cultivated meat and plant-based industries, leaving the entire EU Block lagging behind the rest of the world in such an existential race for complementary proteins.

Not only is this national legislation short-sighted from an economic and environmental point of view, it would also produce an illegitimate deviation from EU Regulation on Novel Foods which already provides a clear framework to assess the safety of novel foods like cultivated meat and seafood, and from the recently-revised CMOs Regulation which includes provisions in favor of the use of meat denominations for plant-based food. This latter issue is expected to be tackled with the forthcoming ruling by the EU Court of Justice, which will determine once and for all whether the EU will take a harmonized approach to plant-based food labels, thus eventually making such a national variation out-of-law. To avoid fragmentation of trade and disruption within the EU Single Market, by virtue of the European Commission’s exclusive competence on the matter, we call upon the highest EU institution to ensure consistency across all Member States, thus suspending any national attempt to legislate on the matter.

Not least, the activation of the precautionary principle to “safeguard Italy’s nation’s heritage” – as recently stated by Italy’s Minister for Health, Orazio Schillaci, would represent an unlawful application of the principle set in Art. 191 of the Treaty on the Functioning of the European Union (TFEU), and a dangerous precedent which would threaten European credibility.

Over the last months, we have collected more than 52,000 signatures against the proposal to prohibit terms such as burger, sausage, steak and others for all plant-based food products. The same proposal had already been rejected by the European Parliament in 2020 and a survey of consumers on attitudes to sustainable food conducted by BEUC in 2020 found that 88% of Italians are not concerned about the naming of veggie ‘burgers’ or ‘sausages’, as long as the products are clearly identifiable as vegetarian/vegan.

To conclude, for these reasons and more, we invite the European Commission to issue a formal opinion opposing final passage of 2023/0469/IT.

Yours Sincerely,

Essere Animali ETS

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UNIONE ITALIANA FOOD

With 51 billion in turnover, 100,000 employees, 550 companies, 18 billion in exports, 900 brands on Italian tables and more than 20 product sectors represented, Unione Italiana Food, a member of Confindustria, is the largest association directly representing product categories in the food sector in Italy.

Among the producers, there are both large multinational food industry groups and companies with an Italian history, many of which have important international projections. Overall, the companies offer a very varied offering in terms of products including a broad offering ofplant-based products.

PLANT BASED PRODUCTS HAVE NOTHING TO DO WITH FOOD CONSISTING OF, ISOLATED FROM OR PRODUCED FROM CELL CULTURES OR TISSUES DERIVED FROM VERTEBRATE ANIMALS

Plant-based products are made from common agricultural raw materials such as legumes (soy, peas, etc.), grains (oats, rice, etc.), seeds (almond), and vegetables or their protein isolates.

The production process of plant-based products therefore follows that of common foods of plant origin. The result is foods and drinks made with ingredients unanimously considered safe by all food safety authorities and which have nothing to do with food consisting of, isolated form or produced from cell cultures or tissues.

PROTECTION OF CONSUMER INFORMATION AND REGULATORY FRAMEWORK IS IN PLACE

Food law establishes the rights of consumers to have access to safe food and accurate and honest information.

In the European Union, labeling rules allow citizens to obtain comprehensive information on the content and composition of food products.

At European and national level, food labeling is regulated by Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011 relating to the provision of food information to consumers.

The Regulation establishes the basis that guarantees a high level of consumer protection in relation to food information, taking into account differences in consumer perceptions and their information needs, while ensuring the smooth functioning of the internal market.

A CONTINUOUSLY ASSERTING MARKET REALITY WITH CLEAR AND CORRECT INFORMATION TO CONSUMERS

Although the market for plant-based products has grown significantly in recent years, the companies belonging to the Unione Italiana Food have been operating in this sector for decades in full compliance with the correctness and transparency of the information provided to the consumer on the characteristics of their products by responding to a request /need for health reasons (intolerances), ethics (vegetarians, vegans, animal welfare) and environmental protection.

From some recent research conducted on consumers, it does not appear that consumers are confused by plant based products denomination; on the contrary, they are generally consumers who read labels and who are very clear about the nature of what they are purchasing. According to a recent quantitative survey by AstraRicerche, approximately 80% of consumers read labels carefully and consider them clear on which ingredients are or are not present, easy to read and understandable, truthful and not misleading.

The European Parliament has also repeatedly reaffirmed the right of plant-based products to use names such as "burger", "cutlets", "vegetable meatballs", etc. on the label. because they refer to a recipe and/or a form of presentation of a food, not to the origin of the raw material (for this reason, however, we cannot speak of hamburgers because "ham" can be understood as a reference to a specific ingredient not present ). These names, therefore, do not give rise to risks of misunderstanding, also because they are always followed by the specification "vegetable".

Given the above, we ask to delete from the draft law the part relating to the ban on the use of the name meat for processed products containing vegetable proteins for two reasons:

-plant based products have nothing to do with food consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals

and

- plant based products are labelled according to by Regulation (EU) No. 1169/2011 relating to the provision of food information to consumers. There are no risks of confusion with products of animal origin and therefore there is no need of a specific ban of the use of the name meat for processed products containing vegetable proteins

Jeremy Coller Foundation - Comments on TRIS Notification 2023/0469/IT (Italy)

Our comments relate to the draft law 2023/0469/IT on ‘’provisions relating to the prohibition on the production and marketing of food and feed consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals, as well as the prohibition on the designation of processed products containing vegetable proteins as meat’’.

TRIS Notification

Paragraph 9

‘’Given the absence, presently, of specific legislation at the European level, it was decided to intervene in a precautionary manner at the national level to protect interests relating to health and cultural heritage. In particular, the draft legislation aims to protect human health by laying down a prohibition on the production and marketing of synthetic foods in implementation of and respecting the precautionary principle set out in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002.’’

Firstly, EU law already providesa regulatory framework for the denomination of food products. Such a framework can be found in the EU's Common Market Organisations Regulation 1308/2013 establishing a common organisation of the markets in agricultural products (“CMOs Regulation,” as amended by Regulation 2021/2117) and its implementing regulations. In our opinion, by virtue of the subsidiarity principle, if a Member State has concerns over a lack of consistent and specific regulatory framework at EU level, such a Member State should then turn to the European Commission to amend these regulations, rather than enacting their own national laws, which poses the risk of fragmenting the EU Single Market by creating distortions in competition between EU business operators.
Secondly, a regulatory framework for novel foods authorisation already exists in EU law. Such a regulatory frameworkis based upon the scientific guidance of the European Food Safety Authority (EFSA), whose mission is to guarantee the safety of food marketed in the EU, thereby addressing concerns over the safety of novel food products for EU consumers.
Thirdly, the precautionary principle only applies to public health and environmental protection. EU law (including as interpreted by the Court of Justice of the European Union) does not point to the application of the precautionary principle to protect cultural heritage as is stated, rendering the precautionary principle partially invalid here.

Draft Text 2023/0469/IT

Article 1, Item 1

‘’This Law lays down provisions designed to ensure the protection of human health and the interests of citizens and to preserve the agri-food heritage, as a set of products that express Italy’s socio-economic and cultural evolution, that is of strategic importance for the national interest.’’

Firstly, as noted above, human health related to novel foods is already protected by a regulatory framework for authorisation provided by EU law, which is implemented by the European Commission. The products in question have been deemed as safe for human consumption under similarly robust novel food regulations and assessment by the relevant authorities in other regions, including Singapore and the United States of America, deeming the precautionary principle partially invalid here.
Secondly, enacting this law would go against protecting Italy’s national interests of protecting food security, as well as maintaining a single market across the EU and enabling fair competition between EU businesses. The Center for Strategic and International Studies has recognised the importance of alternative proteins to improve global food security, food system resilience, global health, national security and economic competitiveness.
Thirdly, enactingthis law would go against the interests of Italian citizens as studies have found that over half of Italian consumers are interested in trying cultivated meat, and this is likely to increase once products become available. With 71% of Italian consumers questioning the impact of conventional meat production on the environment, a majority wish to see governments support new ways of producing meat.

Article 2, Item 1

‘’On the basis of the precautionary principle set out in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002, food business operators and feed business operators shall be prohibited from using in the preparation of food, beverages and feed, selling, holding for sale, importing, producing for export, administering or distributing for food consumption or promoting for those purposes food or feed consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals.’’

Firstly, as noted above, the precautionary principle only applies to public health and environmental protection. EU law (including as interpreted by the Court of Justice of the European Union) does not point to the application of the precautionary principle to protect cultural heritage as is stated, rendering the precautionary principle partially invalid here.

Secondly, a regulatory framework for novel foods authorisation already exists in EU law, based upon guidance from the European Food Safety Authority (EFSA). As stated above, Member States should turn to the European Commission to amend these regulations, rather than enacting their own national laws, at the risk of fragmenting the EU Single Market.

Article 3, Item 1

‘’In order to protect national livestock heritage, recognising its high cultural, socio-economic and environmental value, as well as to adequately support its promotion, while ensuring a high level of protection for human health and the interests of citizen-consumers and their right to information, for the production and marketing within the national territory of processed products containing exclusively vegetable proteins, it shall be prohibited to use: a) legal, common and descriptive names referring to meat, meat production or products made mainly of meat; b) references to animal species or groups of animal species or to animal morphology or animal anatomy; c) specific terms used by butchers, delis or fishmongers; d) names of foods of animal origin representative of commercial uses.’’

Firstly, during the most recent revision of the CMOs Regulation, the European Commission decided not to amend the CMOs Regulation so as to allow the use of meat denominations for vegetable proteins. The same issue is currently being settled by the Court of Justice of the European Union, which could render national variations in the law illegal within less than a year. To prevent fragmentation of trade and disruption within the EU Single Market, there should be consistency in terminology across EU Member States, and any amendments to existing regulation are the responsibility of the European Commission by virtue of its competence in regulating the agricultural market.
Secondly, livestock production has a significant impact on the environment, with animal agriculture contributing approximately 15% of all GHG emissions worldwide. Livestock production and feed account for over 70% of all agricultural land use, whilst cattle and soy for animal feed are both among the top three drivers of deforestation globally. In our opinion, the European Commission should oppose any initiative which undermines the goal of reducing greenhouse gas emissions from the agricultural sector, as per the EU’s commitment under the 2015 Paris Agreement and the policy objectives laid out in the 2020 European Green Deal.
Thirdly, plant-based and cultivated proteins address the environmental and human health issues associated with intensive livestock production. Compared to processed animal-based products, plant-based products also offer a healthier option to consumers in terms of saturated fat, cholesterol, fibre, and a range of other nutrients. Plant-based meat production emits up to 90% fewer greenhouse gas emissions and uses up to 99% less land than conventional meat. When produced with renewable energy, cultivated meat could cut the climate impact of meat by 92% and use up to 95% less land. Diversifying the food system into non-animal-based protein production also reduces reliance on antibiotics, lowering the incidence of antimicrobial resistance, and minimises the risk of emerging zoonotic diseases. All of these objectives contribute to those of the European Green Deal and the EU Farm-to-Fork Strategy, which states that it is necessary to move “to a more plant-based diet with less red and processed meat and with more fruits and vegetables which will reduce not only risks of life-threatening diseases, but also the environmental impact of the food system”.
Finally, various expert studies have recommended that alternative proteins should be supported by governments in line with achieving international climate and nature goals. The UK Government-led Agriculture Breakthrough, supported by the COP28 UAE Presidency, highlights the need for international governments to support research, development and deployment of alternative proteins to address the challenges of food insecurity, climate change and environmental degradation. An analysis commissioned by the UK Foreign, Commonwealth and Development Office (FCDO) and the Climate Works Foundation estimates that governments worldwide need to commit at least $10.1 billion per year to research and commercialisation of alternative proteins to unlock the full benefits. The IPCC special report on land use and climate change also describes a shift towards more plant-based diets as a key opportunity to reduce emissions.

Item 4

‘’The provisions of this Article shall not apply to combinations of foodstuffs of animal origin with other types of food that do not replace nor are alternative to those of animal origin, but are added to them in such combinations.’’

Under the notion of equivalence, there must not be distortions in fair competition between EU business operators marketing substitutable products, which the prohibitions in this draft law would generate. Such a rule would discriminate between substitutable – and thus competitive – products, thereby undermining fair competition between business operators in the Italian and EU market. By definition of the foodstuffs in question aiming to replace or provide an alternative to those of animal origin, European consumers have deemed that the products are equivalent under the standards set by the World Trade Organization (WTO) when determining competitive products (“like products”), as follows: “products are competitive or substitutable when they are interchangeable or if they offer, as the Panel noted, “alternative ways of satisfying a particular need or taste” (KDS75, Korea — Alcoholic Beverages, 2000).

Article 4, Item 1

‘’The Ministry for Health, the regions, the autonomous provinces of Trent and Bolzano, local health authorities, the Carabinieri Command Unit for the Protection of Health, through the relevant dependent Anti-Sophistication and Health Units, the Command of the Forest, Environmental and Agri-food units (CUFA), through the relevant dependent Command Units, the Central Inspectorate of Quality Protection and Fraud Repression of Agri-Food Products (ICQRF) of the Ministry for Agriculture, Food Sovereignty and Forestry, the Guardia di Finanza and the Customs and Monopolies Agency, as well as, for products pertaining to the fish supply chain, the Harbour Masters Corps – Coast Guard, each in accordance with their respective remits, shall carry out checks as to the implementation of this Law. The authorities referred to in the first point shall carry out checks of their respective competence with the support, where necessary, of the specialised staff of the Ministry for Health, the Carabinieri Command Unit for the Protection of Health and local health authorities with specific powers for biological quality and technical checks of a health nature, in relation to potential risks to human health on the basis of the precautionary principle laid down in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002.’’

Firstly, a regulatory framework for novel foods authorisation already exists in EU law, based upon the scientific guidance of the European Food Safety Authority (EFSA). By virtue of the subsidiarity principle, the European Commission retains exclusive competence for authorising the marketing of a novel food, under the continued guidance of EFSA. This is to ensure fair competition between business operators in the EU Single Market by way of enacting harmonised standards.
Secondly, as argued by the Italian Customs and Monopolies Agency during its hearing at the Italian Senate, should a cultivated meat product be assessed as safe and added to the approved novel foods list at EU level, it would not bepossible to control its import to Italy without causing economic uncertainty. This is due to the absence of checks at internal EU borders for imports between Member States, as per the fundamental principle of the free movement of goods on the Single Market, guaranteed by Article 28 of the Treaty on the Functioning of the European Union.

Article 5, Item 1

‘’Unless the act constitutes a criminal offence, food business operators and feed business operators who violate the provisions of Articles 2 and 3 shall be subject to an administrative fine of a minimum of EUR 10 000 up to a maximum of EUR 60 000 or 10% of the total annual turnover achieved in the last financial year closed before the establishment of the infringement, where that amount exceeds EUR 60 000. The maximum penalty may not, however, exceed EUR 150 000. The infringement shall result in the confiscation of the illicit product, the application of the administrative penalties of the prohibition to access contributions, financing or benefits or other disbursements of the same type, however denominated, granted or disbursed by the State, other public bodies or the European Union for the performance of entrepreneurial activities, for a minimum period of one year and up to a maximum of three years, as well as the closure of the production plant, for the same period. Any person who finances, promotes or facilitates in any way the conduct referred to in Articles 2 and 3 shall be subject to the same penalties.’’

Imposing such high penalties on companies would stifle innovation within industry and academia, and prevent Italy, with wider implications in the EU, economically benefitting from the growth of the cultivated meat and plant-based industries. Italian cultivated meat start-ups will be forced to move abroad and interested investors have already started withdrawing from negotiation tables, with capital being diverted to other countries.
Moreover, closing Italy to a growing market that employs highly specialised professionals, including biotechnologists, engineers and chemists, will further worsen Italy’s brain drain, which, over the last ten years, has been constantly growing. An assessment conducted by the Global Methane Hub and Climate Works Foundation estimates that the scaling up of investment into alternative proteins will generate up to 83 million jobs by 2050, which is two-thirds of all jobs created by methane innovation. Total value generation follows a similar pattern to job support, scaling from roughly $160 billion in 2030 to over $700 billion by 2050, encompassing 98% of the growth from methane innovation.

Contribution File

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3 October 2023

Dear European Commission,

Dear Member State representatives,

On 27 July 2023, the Italian government submitted a TRIS notification to the European Commission for draft law 2023/0469/IT. We, the undersigned members of the newly formed Italian Complementary Protein Alliance, are writing to you today in strong opposition to this proposed legislation.

Our consortium represents a cross-section of stakeholders with interests in Italy’s agri-food landscape including food production companies, academic institutions and researchers, civil society, and economic development-focused associations. We have in common the belief that traditional foods made in innovative new ways have an important role to play in Italy, Europe, and the world in the coming years.

Consumers are increasingly demanding more choices for healthy and sustainably produced foods. And while meat consumption across Europe is relatively stable, demand is skyrocketing in other parts of the world and is expected to increase by 50% or more by 2050. Given that food production already accounts for more than a third of climate change-causing greenhouse gases, we can not meet this additional demand for animal protein using current methods without failing to address our current climate and biodiversity loss crises.

Europe has a moral and existential obligation to address this challenge. It also presents a substantive economic opportunity for Member States. By focusing on practices that make conventional agriculture more sustainable and creating a thriving ecosystem for food innovation, we can position Europe as a leader and exporter of complementary proteins that meet global demand. With these new industries come jobs and economic impact that is sorely needed in parts of Europe, especially in Italy.

Not only is this national legislation short-sighted, it is a derogation of EU law. The EU already has a clear framework to assess the safety of novel foods like cultivated meat and seafood (EU 2015/2283). Following a thorough review of risks by the European Food Safety Authority, the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF), composed of representatives from all Member States, votes on whether or not to authorise the product. There is no legal reason for Italy to pre-empt this risk assessment and risk management process.

Italy is also attempting to ban certain denominations for plant-based products. The Commission has previously declined to limit the use of ‘meat terms’ for vegetable proteins, and this issue is pending in the Court of Justice of the European Union. It is within the sole competence of the European Commission to prevent disruptions to fair competition and trade in the EU Single Market, including consistency in terminology for regulated food products. Italy should not be allowed to usurp this role, and there is no evidence to indicate that Italian consumers are confused by the use of these terms or desire regulatory changes.

Ultimately, we trust Italians to make their own food decisions. As long as new food production methods are deemed safe by EFSA and the European Commission, entrepreneurs and food companies should have the right to introduce these products without anti-competitive interference from the government. This is even more important when such interference runs directly contrary to our common goals regarding climate change, food sovereignty, and food security. For these reasons and more, the Italian Complementary Protein Alliance encourages the Commission to issue a formal opinion opposing the final passage of 2023/0469/IT.

Yours Sincerely,

Agricoltura Cellulare Italia APS

AgriFood-Tech Italia

Bruno Cell

The Good Food Institute Europe

Cellular Agriculture Europe

Edible Planet Ventures

Alternative Protein International

Jeremy Coller Foundation

Animal Law Italia

FEAT Research Group

ProVeg International

Mosa Meat B.V.

To Whom It May Concern,

Agricoltura Cellulare Italia APS is an Italian non-profit dedicated to advancing information, research and development in the field of cellular agriculture and its various aspects. Our organization is deeply committed to fostering cooperation among public and private stakeholders, promoting sustainable development, and facilitating innovation in cellular agriculture.

The purpose of this letter is to express our serious concerns regarding the DDL S. 651 recently proposed and approved by the Italian senate, and summarized in the TRIS notification sent to the European Commission on July 27th, 2023.

The proposed law seeks to introduce prohibitions on the production and marketing of food and feed derived from cell cultures or tissues of vertebrate animals, as well as restrictions on the labeling of products containing vegetable proteins as meat [1].

In light of the legislative developments, we wish to draw attention to the following key points of discussion:

European Legislation on Novel Foods: The TRIS notification message cites the absence of specific European legislation as a basis for the proposed national measures [1], invoking the precautionary principle outlined in Article 7 of Regulation (EC) No 178/2002. However, it is essential to note that European legislation does indeed exist in the form of Regulation (EU) 2015/2283 of the European Parliament, which regulates Novel Foods. Given the existence of this comprehensive EU law, we believe the Italian draft legislation and this TRIS notification to be redundant. Moreover, it is important to emphasize that the precautionary principle should only be invoked in the presence of potential risks, and it should not be used to justify arbitrary decisions. Eventually, the precautionary principle requires the measure to be temporary and to encourage research in filling the knowledge gap [2].
Scientific Examination and Consultation: We contend that the perceived adverse effects cited by the Italian Government are a result of an incomplete assessment of the scientific literature due to a lack of consultation with experts and researchers in the field, such as FAO and WHO [3]. Notably, some of the main actors of the Italian alternative proteins ecosystem (e.g., Bruno Cell) have not been heard during the auditions at the Senate and the Chamber. In opposition to our Government, as stated in [2] “The decision-making procedure should be transparent and should involve as early as possible and to the extent reasonably possible all interested parties.” This lack of engagement with relevant experts raises concerns about the accuracy of the scientific examination conducted by the Italian government, as it fails to adhere to the principles outlined in COM(2000) 1 final, which emphasize the importance of comprehensive scientific assessments and the identification of topics for further research [4].
Risk Assessment: The COM(2000) 1 final document underscores the importance of a thorough risk assessment process, which includes hazard identification, hazard characterization, appraisal of exposure, and risk characterization [5] most of which can be already found in FAO and WHO report on food safety of cell-based products [3]. The proposed law does not provide such information based on scientific evidence. Additionally, it is imperative to consider the role of the European Food Safety Authority (EFSA), which oversees the risk assessment and management of Novel Foods within the EU. Our concern lies in the firm belief that EFSA is the most qualified and competent authority to conduct a comprehensive scientific risk assessment concerning cell-based food products.
European Single Market: As argued by the Italian Customs and Monopolies Agency during its hearing at the Italian Senate, we want to underline that the proposed ban would not prevent the import of cell-based products into Italy, thanks to the presence of the single market [6]. Therefore, we express our concerns about how the proposed law would limit and pose threats to the free trade of goods within the Schengen area once a cell-based product is approved by the EU Commission.

We respectfully implore you to consider the validity of the criticism and the gravity of the concerns that we have expressed in this letter and their potential implications for the future of cellular agriculture and food innovation within the European Union. We fervently hope that our points will be given the earnest consideration they merit, and we remain open to engaging in constructive dialogue to address how the proposed law is not aligned with EU principles and regulations.

Best regards,

Nike Schiavo

on behalf of Agricoltura Cellulare Italia APS

References

[1] TRIS Notification: 2023/0469/IT

[2] COM(2000) 1 final

[3] FAO & WHO. 2023. Food safety aspects of cell-based food. Rome.

[4] COM(2000) 1 final, Section 5.1.1.

[5] COM(2000) 1 final, Section 5.1.2.

[6] Article 26 and Articles 28 to 37 of the Treaty on the Functioning of the European Union (TFEU)

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