{"id":1430,"date":"2025-03-24T03:05:36","date_gmt":"2025-03-24T03:05:36","guid":{"rendered":"https:\/\/www.fratinivergano.eu\/en\/?post_type=trade-perspectives&#038;p=1430"},"modified":"2025-03-24T14:22:15","modified_gmt":"2025-03-24T14:22:15","slug":"24-march-2025","status":"publish","type":"trade-perspectives","link":"https:\/\/www.fratinivergano.eu\/en\/trade-perspectives\/24-march-2025\/","title":{"rendered":"24 March 2025"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li><a href=\"#EULAW\" data-type=\"internal\" data-id=\"#EULAW\">The EU\u2019s <em>Industrial Action Plan for the European automotive sector<\/em>: Reconciling \u201c<em>European content requirements<\/em>\u201d with WTO Rules?<\/a><\/li>\n\n\n\n<li><a href=\"#Indonesia\" data-type=\"internal\" data-id=\"#Indonesia\">Indonesia amends its regulation on genetically engineered food products: New standards on genome-editing and guidelines on food safety approval<\/a><\/li>\n\n\n\n<li><a href=\"#FOODLAW\">A new petition to prohibit aspartame reignites decades of debate on the artificial sweetener\u2019s health impacts<\/a><\/li>\n\n\n\n<li><a href=\"#EULegislation\">Recently adopted EU legislation<\/a><\/li>\n<\/ul>\n\n\n\n<h1 class=\"wp-block-heading has-text-align-left\" id=\"EULAW\"><strong>The EU&#8217;s <em>Industrial Action<\/em> <em>Plan for the European automotive sector<\/em>: Reconciling \u201c<em>European content requirements<\/em>\u201d with WTO Rules?<\/strong><\/h1>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>By Stella Nalwoga, Amanda Carlota, and Paolo R. Vergano<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On 5 March 2025, the European Commission (hereinafter, Commission) published a <a href=\"https:\/\/transport.ec.europa.eu\/document\/download\/89b3143e-09b6-4ae6-a826-932b90ed0816_en?filename=Communication%20-%20Action%20Plan.pdf\">Communication<\/a> on the <em>Industrial Action Plan for the European automotive sector<\/em> (hereinafter, Industrial Action Plan), which appears to signal a decisive shift in the EU\u2019s industrial policy. The <em>Industrial Action Plan<\/em> aims at supporting the European automotive industry\u2019s \u201c<em>transition to clean, connected, and increasingly automated vehicles, to guarantee its international competitiveness<\/em>\u201d. A key aspect of the Industrial Action Plan is the potential introduction of local content requirements (hereinafter, LCRs) for electric vehicle batteries. This article examines the <em>Industrial Action Plan<\/em>\u2019s core elements, its potential legal and commercial implications, and the broader question of whether the EU can succeed in balancing industrial policy ambitions with its WTO commitments.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Keeping up with the changing global automotive industry<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The global automotive industry has been undergoing a rapid structural transformation, including the objective of reducing the transportation sector\u2019s contribution to greenhouse gas emissions by manufacturing zero-emission vehicles, notably electric vehicles. According to the Commission, electric vehicles already make up \u201c<em>a significant share of global sales<\/em>\u201d and are expected to eventually become the \u201c<em>dominant market segment<\/em>\u201d. The European automotive industry faces a competitive disadvantage due to its slow transition to battery and software-driven mobility, as well as the strong competition from the US and China, which support their industries with fiscal incentives and\/or subsidy schemes, often tied to LCRs, namely policies that condition benefits, such as market access or subsidies, to the use of local goods or services.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Against this backdrop, the <em>Industrial Action Plan<\/em> sets the stage for the EU\u2019s \u201c<em>decisive action<\/em>\u201d and commitment to support the European automotive industry. The <em>Industrial Action Plan <\/em>builds on the Commission\u2019s <a href=\"https:\/\/commission.europa.eu\/document\/download\/10017eb1-4722-4333-add2-e0ed18105a34_en\"><em>Competitiveness Compass<\/em><\/a> and on the Commission\u2019s Communication on a <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_25_550\"><em>Clean Industrial Deal<\/em><\/a>, and incorporates insights from recently concluded targeted stakeholder <a href=\"https:\/\/transport.ec.europa.eu\/dialogue-future-automotive-industry_en\">consultations<\/a> and an <a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14487-Future-of-the-European-automotive-industry\/public-consultation_en\">open public consultation<\/a> on the future of the European automotive industry. The <em>Industrial <\/em><em>Action Plan<\/em> presents \u201c<em>concrete measures to help secure global competitiveness of the European automotive industry and maintain a strong European production base<\/em>\u201dthrough actions in five key areas, namely: 1) Innovation and digitalisation; 2) Clean mobility; 3) Competitiveness and supply chain resilience; 4) Skills and social dimension; and 5) Boosting market access; thereby aiming at ensuring a level playing field and guaranteeing economic security.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>European preference criteria in procurement<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The first core element of the <em>Industrial Action Plan<\/em> is its focus on \u201c<em>Competitiveness and supply chain resilience<\/em>\u201d, particularly in developing <em>\u201ca cost-competitive\u201d <\/em>domestic battery industry for electric vehicles. The <em>Industrial Action Plan<\/em> seeks to increase European value addition along the supply chain to more than 50% by 2030, and expressly states that \u201c<em>European content requirements on battery cells and components in EVs sold in the EU will be addressed in upcoming legislation<\/em>, including the <em>Industrial Decarbonisation Accelerator Act<\/em> <em>and the<\/em> <em>Circular Economy Act<\/em>, <em>in line with the Union\u2019s international legal commitments<\/em>\u201d, adding that \u201c<em>these requirements will reflect the expected gradual ramp-up curve of domestic production capacity<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In a press conference following the adoption of the <em>Industrial Action Plan<\/em>, the European Commissioner for Sustainable Transport and Tourism, <em>Apostolos Tzitzikostas<\/em>, <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/speech_25_693\">emphasised<\/a> that batteries, which \u201c<em>account for 30-40% of a typical electric car\u2019s value<\/em>\u201d, were crucial for jobs and economic competition and added that, \u201c<em>to compete, Europe needs its own supply. That means producing them ourselves. And alongside finance, we are considering European content requirements for batteries and components sold here<\/em>\u201d. However, details on these \u201c<em>European content requirements<\/em>\u201d are still sparse and the Commission only <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_25_550\">notes<\/a> that the EU\u2019s forthcoming <em>Industrial Decarbonisation Accelerator Act<\/em> would pursue to \u201c<em>increase demand for EU-made clean products by introducing sustainability, resilience, and \u2018made in Europe\u2019 criteria in public and private procurements<\/em>\u201d. More specifically, the Commission foresees to review the EU\u2019s Public Procurement Framework in 2026 and to introduce, <em>inter alia<\/em>, \u201c<em>European preference criteria in<\/em> <em>public procurement for strategic sectors<\/em>\u201d. In the context of the automotive industry, LCRs could require electric vehicles\u2019 batteries and components to meet a minimum percentage of European-origin materials and production in order to qualify for public procurement contracts and\/or subsidies or other advantages to be conferred by the governments of the EU Member States to business operators in the EU\u2019s automotive industry.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This change in approach from an open-market to a \u201c<em>European preference<\/em>\u201d appears to come out of the playbook of countries relying heavily on LCRs and could raise substantial legal concerns in view of the EU\u2019s international obligations, notably under the WTO non-discrimination principles contained in the <a href=\"https:\/\/www.wto.org\/english\/docs_e\/legal_e\/06-gatt_e.htm\"><em>General Agreement on Tariffs and Trade 1994<\/em><\/a> (hereinafter, GATT 1994), the <a href=\"https:\/\/www.wto.org\/english\/docs_e\/legal_e\/18-trims_e.htm\"><em>Agreement o<\/em><\/a><a href=\"https:\/\/www.wto.org\/english\/docs_e\/legal_e\/18-trims_e.htm\"><em>n Trade-Related Investment Measures<\/em><\/a> (hereinafter, TRIMs Agreement), and the <a href=\"https:\/\/www.wto.org\/english\/tratop_E\/gproc_e\/gp_gpa_e.htm\"><em>Agreement on Government Procurement<\/em><\/a> (hereinafter, WTO GPA), as well as the provisions on prohibited subsidies of the <a href=\"https:\/\/www.wto.org\/english\/docs_e\/legal_e\/24-scm.pdf\"><em>Agreement on Subsidies and Countervailing Measures<\/em><\/a> (hereinafter, SCM Agreement) and under the EU\u2019s bilateral trade agreements. While the Commission has stated that the LCRs would be \u201c<em>in line with the Union\u2019s international legal commitments<\/em>\u201d, this will very much depend on their design and implementation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In general terms, LCRs imposed in the context of procurement intended for public purposes could be challenged as a violation of the national treatment obligation under Article IV of the WTO GPA, which requires the signatories, including the EU and its Member States, to provide goods, services, and suppliers from other GPA parties treatment no less favourable than that accorded to domestic counterparts. The same obligation would apply to advantages conferred by governments to private entities conditioned on the use of local inputs vis-\u00e0-vis foreign inputs under Article III:4 of the <em>GATT 1994<\/em> and Article 2 of the <em>TRIMs Agreement<\/em>. Lastly, financial incentives granted to private entities \u201c<em>contingent, whether solely or as one of several other conditions, upon the use of domestic over imported goods<\/em>\u201d could also be considered as prohibited subsidies under Article 3.1(b) of the <em>SCM Agreement.<\/em> These considerations underscore the legal complexity and potential risk of legal challenges that the EU could face under both multilateral and bilateral trade commitments, depending on how such measures are ultimately crafted and implemented.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Refining rules of origin to level the playing field<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The second core component of the <em>Industrial Action Plan<\/em> concerns boosting market access, ensuring a level playing field and guaranteeing economic security. Under that broad theme, the Commission foresees utilising PTAs to obtain market access and regulatory convergence and use other trade policy instruments, such as rules of origin, trade defence, and investment regulation, to ensure a level playing field. With respect to rules of origin, the Commission intends to engage with the automotive industry and EU Member States on \u201c<em>the approach applied to preferential rules of origin to ensure that they contribute and support the long-term competitiveness of the EU automotive sector<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Preferential rules of origin in PTAs establish the \u2018<em>economic nationality<\/em>\u2019 of goods via specific criteria delineating where the goods were produced, manufactured, or substantially transformed, in order to ensure that only goods \u2018<em>originating<\/em>\u2019 from the PTA Parties benefit from the trade preferences. For example, in the recently concluded <a href=\"https:\/\/policy.trade.ec.europa.eu\/eu-trade-relationships-country-and-region\/countries-and-regions\/mercosur\/eu-mercosur-agreement\/text-agreement_en\"><em>EU-Mercosur Partnership Agreement<\/em><\/a><em>, <\/em>the EU value threshold for non-originating material in electric vehicle batteries is 50%. This means that 50% of the value of the electric vehicle battery must originate from the Mercosur countries for the good to qualify for preferential tariffs. The European Commission intends to open a consultation with industry and EU Member States on preferential rules of origin, which is an important opportunity to comment on the market access conditions for electric vehicles and their components.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Given that the batteries, which constitute the most expensive single component in electric vehicles, are primarily sourced from China, South Korea, or Japan, the formulation of these rules could significantly impact third-country suppliers and trading partners negotiating PTAs with the EU, especially from Asia. If the EU were to set stricter non-originating material thresholds, it could limit the ability of partner countries to benefit from preferential tariffs, thereby restricting their electric vehicle exports to the EU.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Balancing industrial policy objectives with WTO commitments<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EU\u2019s <em>Industrial Action Plan for the European automotive sector<\/em> appears to potentially represent a significant shift in the EU\u2019s industrial and trade policy, but raises questions regarding the compatibility of its future measures with the EU\u2019s WTO commitments. Possible future measures, such as local content requirements and stricter rules of origin, if implemented without careful calibration, could run afoul of WTO rules and disrupt global supply chains, even for its own automotive sector.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It is not surprising that the industry has received the <em>Industrial Action Plan<\/em> with mixed reactions. The <em>European Association of Automotive Suppliers<\/em> <a href=\"https:\/\/www.clepa.eu\/wp-content\/uploads\/2025\/03\/PR_automotive-action-plan-charts-positive-first-steps-but-misses-addressing-crucial-needs-of-the-supplier-industry.pdf\">argues<\/a> that \u201c<em>the goal should be a level playing field for competition while preserving the advantages of production at scale and a globally connected supply chain<\/em>\u201d. The Commission announced that it would now engage with the European Parliament and the Council of the EU to swiftly implement the proposed actions. The next phase will be crucial for interested stakeholders, who should actively engage with policymakers to ensure that policies and market access conditions are structured in a legally sound and commercially viable manner.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>For any additional information or legal advice on this matter, please contact Paolo R. Vergano<\/em><\/strong><\/p>\n\n\n\n<h1 class=\"wp-block-heading\" id=\"Indonesia\"><strong>Indonesia amends its regulation on genetically engineered food products: New standards on genome-editing and guidelines on food safety approval<\/strong><\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">&nbsp;<strong>By&nbsp;<em>Alya Mahira, Caitlynn Nadya, and Paolo R. Vergano<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On 28 November 2024, Indonesia\u2019s <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/309970\/peraturan-bpom-no-19-tahun-2024\"><em>Food and Drug Supervisory Agency Regulation No. 19 of 2024 on the Control of Genetically Engineered Food Products<\/em><\/a> (hereinafter, <em>Badan Pengawas Obat dan<\/em> <em>Makanan<\/em>, BPOM Regulation No. 19\/2024) entered into force. The Regulation, which repealed <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/183200\/peraturan-bpom-no-6-tahun-2018\"><em>BPOM Regulation No. 6 of 2018<\/em><\/a>, provides, <em>inter alia<\/em>, for the following changes: 1) The introduction of a new section on genome-edited products; 2) Updated labelling requirements for food containing genetically modified (hereinafter, GM) ingredients; and 3) Guidelines for the food safety approval process of both genetically engineered food products and those with stacked genes (<em>i.e.<\/em>, GM crops that contain multiple introduced genes, each conferring distinct traits such as pest resistance, herbicide tolerance, and extended shelf life, resulting in a single crop variety with multiple beneficial characteristics). This article discusses the key changes by <em>BPOM Regulation No. 19\/2024 <\/em>and their commercial implications for food business operators, particularly regarding their regulatory responsibilities and market opportunities.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Regulation of genetically engineered food products in Indonesia<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">GM food refers to food produced from or containing raw materials, additives, or other ingredients derived from genetic modification processes or genetically modified organisms. The regulation of biosafety and food safety for the commercialisation of GM food products was introduced in 2012 under <a href=\"https:\/\/www.fao.org\/fileadmin\/user_upload\/gmfp\/docs\/HK.03.1.23.03.12.1563.pdf\"><em>BPOM Regulation No. HK.03.1.23.03.12.1563\/2012<\/em><\/a>, which was later repealed by <em>BPOM Regulation No. 6\/2018<\/em>. As with the previous framework, <em>BPOM Regulation No. 6\/2018<\/em> intends to safeguard consumers from GM food products that do not meet food safety standards. It requires food business operators to obtain food safety approval before producing or importing GM foods. According to the Head of BPOM, <em>Taruna Ikrar,<\/em> <em>BPOM Regulation No. 19\/2024 <\/em>was issued to align the rules with progress in \u201c<em>knowledge, technology and laws<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The new Regulation retains several requirements under <em>BPOM Regulation No. 6 of 2018<\/em>, while introducing a number of changes. More specifically, <em>BPOM Regulation No. 19\/2024<\/em> clarifies which GM foods are exempt from labelling requirements,introduces new requirements for food business operators seeking safety approvals, and updates the guidelines for the safety assessments of GM food derived from microorganisms and stacked genes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Exemptions for the GM labelling requirements<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Indonesia\u2019s Food and Drug Supervisory Agency has long required food business operators producing and importing GM foods for commercial distribution to indicate \u201c<em>GENETICALLY MODIFIED PRODUCT<\/em>\u201d on the label. Article 10 of <em>BPOM Regulation No. 19\/2024<\/em> clarifies the types of GM products exempt from this requirement, namely GM foods that have been purified and are in the form of oils, fats, sugars, or starches, provided that they are not protein-based and contain no detectable GM deoxyribonucleic acid (DNA) or protein components. Examples of such products include high-fructose corn syrup derived from GM corn or soybean oil from GM soybean crops.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This exemption was introduced as the purification process removes the original GM DNA, thereby making the purified products identical to their non-GM counterparts. This exemption would reduce regulatory burdens and compliance costs for economic operators dealing with purified GM-derived products. In line with the previous framework, the labelling requirement applies to GM food products containing at least 5% of GM DNA content and to processed foods containing multiple GM ingredients. In accordance with Article 11 of <em>BPOM Regulation No. 19\/2024<\/em>, the percentage of GM DNA is calculated separately for each ingredient.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Enhanced monitoring and compliance requirements for food business operators<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Article 13(2) of <em>BPOM Regulation No. 19\/2024<\/em> introduces a standardised format for sample submission of GM foods, which were not previously regulated. Food business operators intending to obtain food safety approvals are now required to submit samples of both the approved GM foods and their non-GM counterparts (control sample) in the form of purified GM food DNA or flour samples of at least 500 grams. <em>BPOM Regulation No. 19\/2024<\/em> emphasises the protection of human health by requiring that food business operators producing or importing GM food or processed food containing GM products found to have adverse effects on human health will have their food safety approval revoked, requiring mitigation measures, such as the immediate withdrawal of affected products from the market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This stringent control increases the responsibility of food business operators, requiring them to be more vigilant in ensuring compliance with food safety standards. Article 7 of <em>BPOM Regulation No. 6\/2018<\/em> introduces a provision allowing the transfer of ownership of a food safety approval for GM products to another party, provided that the product remains identical to the previously approved version and is supported by documentation. This flexibility would reduce administrative burdens for business transactions, allowing companies to retain the food safety approval without undergoing a new approval process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Enhancing the regulation to genome-edited and genetically engineered products<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>BPOM Regulation No. 19\/2024 <\/em>introduces new food safety standards for genome editing, which refers to a biotechnology technique for modifying genes with greater simplicity, precision, and efficiency to produce enhanced food products, and for genetically engineered products derived from stacked genes and engineered microorganisms. Under Article 9, food produced via genome editing will either be classified as GM food derived from genome editing or non-GM food, depending on an assessment conducted by the GM Products Biosafety Commission, which is responsible for advising the relevant Ministers on policy formulation and issuing GM product certificates. If the GM product is determined to be a gene-edited food, food business operators or importers must obtain a food safety approval certificate issued by the GM Products Biosafety Commission.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>BPOM Regulation No. 19\/2024 <\/em>introduces new guidelines for the safety approval of GM food derived from stacked genes and purified GM products derived from engineered microorganisms, such as amino acids and preservatives, which were previously not regulated. With regard to stacked genes, an applicant must ensure that each GM strain used in the crossbreeding has obtained prior food safety approval. For imported products, applicants must provide test results from accredited laboratories that adhere to good laboratory practices or have mutual recognition agreements with BPOM.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To date, countries within the Association of Southeast Asian Nations (ASEAN) region have reached mutual recognition agreements on product safety standards with BPOM. These arrangements allow BPOM-certified products to be recognised in countries with mutual recognition agreements with Indonesia without requiring new approval processes, facilitating market entry and increasing opportunities for intra-ASEAN trade. To obtain an approval for purified GM products derived from engineered microorganisms, applicants must submit, <em>inter alia<\/em>, detailed information on production processes, genetic modifications, and the intended usage across food categories. The related additional testing requirements may raise costs and extend approval timelines for food businesses operators. However, they could strengthen product credibility by ensuring compliance with Indonesia\u2019s legal framework and mitigating regulatory risks.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Trade implications<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">While <em>BPOM Regulation No. 19\/2024 <\/em>has entered into force, food safety approvals issued under <em>BPOM Regulation No. 6\/2018<\/em> remain valid, unless they conflict with the new provisions. However, a 12-month grace period is granted for previously approved GM foods that require adjustments to comply with the clarified labelling requirements, or, if necessary, submit a new food safety approvals application. During this period, affected food business operators can start engaging with accredited laboratories to start the necessary testing or documentation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Stricter oversight enhances consumer confidence and regulatory alignment, potentially improving market access for businesses that meet the new standards. However, the added costs and testing requirements may create barriers, particularly for smaller food business operators and importers.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>For any additional information or legal advice on this matter, please contact Paolo R. Vergano<\/em><\/strong><\/p>\n\n\n\n<h1 class=\"wp-block-heading\" id=\"FOODLAW\"><strong>A new petition to prohibit aspartame reignites decades of debate on the artificial sweetener\u2019s health impacts<\/strong><\/h1>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>By&nbsp;&nbsp;<em>Amanda Carlota<\/em>, <em>Ignacio Carre\u00f1o Garc\u00eda<\/em>&nbsp;&nbsp;and&nbsp;&nbsp;<em>Tobias Dolle<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On 4 February 2025 a coalition comprised of the consumer advocacy group <em>Foodwatch<\/em>, the French League Against Cancer(<em>i.e.<\/em>, <em>La Ligue contre le Cancer<\/em>), and the mobile app company <em>Yuka<\/em>, launched a <a href=\"https:\/\/www.foodwatch.org\/en\/no-to-aspartame-in-our-food-and-drinks\">petition<\/a> to prohibit the artificial sweetener aspartame in the EU, claiming that it is linked to cancer, cardiovascular disease, type 2 diabetes, and microbiome disorders.This article examines recent studies on the health impacts of aspartame and evaluates whether the findings would indeed justify the prohibition of aspartame on the basis of the EU\u2019s \u201c<em>precautionary principle<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Aspartame\u2019s authorisation as an additive in the EU<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aspartame is a low-calorie artificial sweetener that is authorised to be used in the EU as a food additive under the E-number E 951 to sweeten foods and beverages and as a table-top sweetener, pursuant to <a href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2008:354:0016:0033:en:PDF#:~:text=This%20Regulation%20lays%20down%20rules,fair%20practices%20in%20food%20trade%2C\"><em>Regulation (EC) No 1333\/2008 of the European Parliament and of the Council on food additives<\/em><\/a>. Aspartame is approximately 200 times sweeter than table sugar, so much lower amounts are needed to achieve the same level of sweetness. As such, aspartame is commonly used as a substitute for sugar in foods and beverages, especially those that are marketed as no- or low-calorie, such as in the \u201c<em>diet<\/em>\u201d versions of popular carbonated beverages.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The scientific controversy surrounding aspartame\u2019s safety<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Since its discovery in 1965, aspartame has been the subject of controversy due to concerns about its possible health impacts. As such, the US Food and Drug Administration, which was the first to <a href=\"https:\/\/archives.federalregister.gov\/issue_slice\/1974\/7\/26\/27316-27320.pdf#page=2\">approve<\/a> aspartame in 1974 for use as a table-top sweetener and in chewing gum, cold breakfast cereals, and dry bases for certain foods, describes it as \u201c<em>one of the most studied food additives in the human food supply<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In 2013, the European Food Safety Authority (hereinafter, EFSA) <a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/epdf\/10.2903\/j.efsa.2013.3496\">re-evaluated<\/a> the safety of aspartame and concluded that aspartame and its breakdown products were safe for the general population, at current levels of exposure. The EFSA has been tasked with <a href=\"https:\/\/open.efsa.europa.eu\/questions\/EFSA-Q-2011-00727\">re-evaluating<\/a> the safety of the salt of aspartame-acesulfame, a sweetener which is a mixture of aspartame and acesulfame K. The EFSA <a href=\"https:\/\/www.efsa.europa.eu\/en\/topics\/topic\/aspartame\">indicated<\/a> that, as part of the re-evaluation, it would update its dietary exposure assessment of aspartame. The EFSA <a href=\"https:\/\/www.efsa.europa.eu\/sites\/default\/files\/2024-03\/02a-state-of-play-lessons-learnt-from-re-evaluation-sweeteners.pdf\">aims<\/a> to publish its opinion within this year.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On 14 July 2023, the World Health Organization (hereinafter, WHO) released the results of two \u201c<em>independent but complementary<\/em>\u201d assessments of the health impacts of aspartame, conducted by the <em>International Agency for Research on Cancer<\/em> (hereinafter, IARC) and the Joint WHO\/Food and Agriculture Organisation\u2019s <em>Expert Committee on Food Additives<\/em> (hereinafter, JEFCA), respectively. On the one hand, the IARC <a href=\"https:\/\/www.who.int\/publications\/m\/item\/summary-of-findings-of-the-evaluation-of-aspartame-at-the-international-agency-for-research-on-cancer-(iarc)-monographs-programme-s-134th-meeting--and-the-joint-fao-who-expert-committee-on-food-additives-(jecfa)-96th-meeting\">concluded<\/a> that aspartame was \u201c<em>possibly carcinogenic to humans<\/em>\u201d, citing \u201c<em>limited evidence<\/em>\u201d for cancer in humans (specifically for hepatocellular carcinoma, a type of liver cancer) and experimental animals, as well as \u201c<em>limited mechanistic evidence<\/em>\u201d that aspartame \u201c<em>exhibits key characteristics of carcinogens<\/em>\u201d. On the other hand, the JEFCA <a href=\"https:\/\/www.who.int\/publications\/m\/item\/ninety-sixth-meeting-joint-fao-who-expert-committee-on-food-additives-(jecfa)\">concluded<\/a> that the acceptable daily intake of aspartame, namely 40 mg per kilogram of body weight per day, \u201c<em>does not pose a health concern\u201d<\/em>, as \u201c<em>with a can of diet soft drink containing 200 or 300 mg of aspartame, an adult weighing 70kg would need to consume more than 9-14 cans per day to exceed the acceptable daily intake, assuming there is no other intake from other food sources<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The EU\u2019s Precautionary Principle<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The joint petition by <em>Foodwatch<\/em>, the French League Against Cancer, and <em>Yuka<\/em> calls on the European Commission (hereinafter, Commission) to prohibit aspartame on the basis of the \u201c<em>precautionary principle<\/em>\u201d set out in Article 7(1) of the EU\u2019s <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2002\/178\/oj\/eng\"><em>Regulation (EC) No. 178\/2002 laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety<\/em><\/a><em>, <\/em>which states that \u201c<em>in specific circumstances where, following the assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The invocation of the precautionary principle appears to be misplaced, as it appears to be based on a misinterpretation of the term \u201c<em>possibly carcinogenic to humans\u201d. <\/em>The IARC <a href=\"https:\/\/monographs.iarc.who.int\/wp-content\/uploads\/2019\/07\/Preamble-2019.pdf\">emphasises<\/a> that the term had no quantitative significance and was merely used as a descriptor of the strength of evidence of carcinogenicity in humans, and that \u201c<em>limited evidence<\/em>\u201d of carcinogenicity simply means that \u201c<em>a causal interpretation of the positive association observed in the body of evidence on exposure to the agent and cancer is credible, but<\/em> <em>chance, bias, or confounding could not be ruled out with reasonable confidence<\/em>\u201d. Notably, other agents that the IARC has <a href=\"https:\/\/monographs.iarc.who.int\/list-of-classifications\">classified<\/a> as \u201c<em>possibly carcinogenic to humans<\/em>\u201d include aloe vera extract, gingko biloba extract, and pickled vegetables used in traditional Asian cuisine \u2013 none of which have generated the same amount of controversy as aspartame.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The difference between a hazard and a risk, and the regulatory relevance<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">When adopting measures pursuant to the precautionary principle, it is important to draw a distinction between hazard and risk. Under Article 3 of <em>Regulation (EC) No. 178\/2002<\/em> a hazard is \u201c<em>a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect<\/em>\u201d, while risk is \u201c<em>a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The IARC is not a food safety body and its responsibility is primarily to evaluate whether an agent is a cancer hazard, not to measure its cancer risk. Thus, the IARC\u2019s assessment that aspartame is \u201c<em>possibly carcinogenic to humans<\/em>\u201d does not consider whether or not the levels of aspartame currently used in foods and beverage increase the risk of cancer (see <em>Trade Perspectives, <\/em><a href=\"http:\/\/www.fratinivergano.eu\/en\/17-july-2023\/#Foodlaw\">Issue No. 14 of 17 July 2023<\/a>). The JEFCA, on the other hand, is a food safety body and, as such, assesses cancer risk. Its conclusion that \u201c<em>dietary exposure to aspartame does not pose a health concern<\/em>\u201d indicates that it did not consider aspartame to be a cancer risk.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">With respect to food safety, the EU follows a risk-based, not hazard-based, approach. This means that the mere presence of an agent classified as a cancer hazard, such as aspartame, does not form the basis for<em> ex-ante <\/em>measures, such as a prohibition. Rather, the level of exposure to the agent and the probability of adverse effects must also be considered. The precautionary principle may only be invoked after all available information has been assessed and, crucially, when the possibility of harmful effects on health has been identified, but where scientific uncertainty still exists (see <em>Trade Perspectives, <\/em>Issues <a href=\"http:\/\/www.fratinivergano.eu\/en\/20-november-2023\/\">No. 21 of 20 November 2023<\/a> and <a href=\"http:\/\/www.fratinivergano.eu\/en\/11-march-2024\/#Italy%20meat%20law\">No. 5 of 11 March 2024<\/a>). In other words, there must already be a known risk to health.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To date, neither the JEFCA nor the EFSA have associated aspartame with any cancer risks that would justify the application of the precautionary principle. Therefore, prohibiting aspartame in the EU would be illegal, as well as, disproportionate, and unnecessary. And even if these entities were to uncover health risks in the future, an outright prohibition may nevertheless not be appropriate, as Article 7(2) of <em>Regulation (EC) No. 178\/2002<\/em> on the precautionary principle requires that any measures be \u201c<em>proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community<\/em>\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Any measure must also conform to Article 2 of the <a href=\"https:\/\/www.wto.org\/english\/tratop_e\/sps_e\/spsagr_e.htm\"><em>WTO Agreement on the Application of Sanitary and Phytosanitary Measures<\/em><\/a>, which states that any measure applied to protect human health must be based on \u201c<em>scientific principles<\/em>\u201d and maintained on \u201c<em>sufficient scientific evidence<\/em>\u201d,\u201c<em>must not arbitrarily or unjustifiably discriminate between Members<\/em>\u201d, and \u201c<em>shall not be applied in a manner which would constitute a disguised restriction on international trade<\/em>\u201d, while Article 5 directs WTO Members to ensure that such measures are \u201c<em>not more trade-restrictive than required to achieve their appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility<\/em>\u201d. Therefore, before applying the precautionary principle, the EU must carefully consider both the scientific basis for the measure, as well as the measure\u2019s conformity with the EU\u2019s obligations under international agreements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>No prohibition in the immediate future?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The current lack of sufficient scientific evidence that aspartame does indeed increase the risk of cancer means that there is no legal basis for its prohibition in the EU. If aspartame were to be prohibited, its widespread use in various products means that manufacturers would need to seek substitutes \u2013 alternatives include neotame, an aspartame analogue, other \u201c<em>natural<\/em>\u201d sweeteners, like honey, stevia, and monkfruit, as well as \u201c<em>sugar alcohols<\/em>\u201d, such as xylitol, erythritol, and sorbitol. Manufacturers would incur significant costs in re-formulating and re-labelling their products.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Interested stakeholders should monitor the developments in relation to aspartame and the salt of aspartame-acesulfame. If new scientific evidence were to emerge confirming that aspartame does indeed pose a cancer risk, then the Commission would be required to take the necessary measures pursuant to <em>Regulation (EC) No. 178\/2002, <\/em>including the removal of aspartame from the list of food additives pursuant to <em>Regulation (EC) No 1333\/2008<\/em>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>For any additional information or legal advice on this matter, please contact Ignacio&nbsp;<\/em><\/strong><strong><em>Carre\u00f1o Garcia<\/em><\/strong><\/p>\n\n\n\n<h1 class=\"wp-block-heading\" id=\"EULegislation\"><strong>Recently adopted EU legislation<\/strong><\/h1>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Trade Law<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202500530\">Commission Delegated Regulation (EU) 2025\/530 of 30 October 2024 amending Annexes I and III to Council Regulation (EC) No 2173\/2005 following a Voluntary Partnership Agreement with the Republic of Ghana for a Forest Law Enforcement, Governance and Trade (FLEGT) licensing scheme for imports of timber into the European Union<\/a><\/em><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202500542\">Council Decision (EU) 2025\/542 of 18 March 2025 establishing the position to be taken on behalf of the European Union regarding the decision of the Participants to the Sector Understanding on Export Credits for Civil Aircraft contained in Annex III to the Arrangement on Officially Supported Export Credits on amendments to that Sector Understanding <\/a>&nbsp;<\/em><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Trade Remedies<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202500500\">Commission Implementing Regulation (EU) 2025\/500 of 13 March 2025 imposing definitive countervailing duties on imports of certain aluminium road wheels originating in Morocco<\/a><\/em><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202500482\">Commission Implementing Regulation (EU) 2025\/482 of 14 March 2025 making imports of barium carbonate originating in the People\u2019s Republic of China and India subject to registration<\/a><\/em><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202500468\">Commission Implementing Regulation (EU) 2025\/468 of 12 March 2025 opening and providing for the management of Union tariff quotas for certain processed agricultural products originating in the Republic of Chile<\/a><\/em><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Food Law<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202500505\">Commission Implementing Regulation (EU) 2025\/505 of 19 March 2025 amending Implementing Regulation (EU) 2022\/632 as regards the prolongation of the temporary measures concerning specified fruits originating in Argentina, Brazil, South Africa, Uruguay and Zimbabwe to prevent the introduction into and the spread within the Union territory of the pest Phyllosticta citricarpa (McAlpine) Van der Aa<\/a><\/em><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202500513\">Commission Implementing Regulation (EU) 2025\/513 of 20 March 2025 amending the Annex to Implementing Regulation (EU) 2023\/2059 as regards the inclusion of certain goods of animal origin in the list of rest-of-the-world commodities<\/a><\/em><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Amanda Carlota, Ignacio Carre\u00f1o Garc\u00eda, Tobias Dolle, Alya Mahira, Caitlynn Nadya, Stella Nalwoga, and Paolo R. Vergano contributed to this issue.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Follow us on Bluesky <\/em><a href=\"https:\/\/bsky.app\/profile\/fratinivergano.bsky.social\"><em>@fratinivergano.bsky.social<\/em><\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To subscribe to&nbsp;<em>Trade Perspectives<\/em>\u00a9, please click&nbsp;<a href=\"https:\/\/mailchi.mp\/fratinivergano.eu\/tradeperspectives_subscription\">here<\/a>. To unsubscribe, please click&nbsp;<a href=\"mailto:TradePerspectives@fratinivergano.eu?subject=Trade%20Perspectives%20Subscription\">here<\/a>.<\/p>\n","protected":false},"author":2,"featured_media":1435,"template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1430","trade-perspectives","type-trade-perspectives","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/trade-perspectives\/1430","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/trade-perspectives"}],"about":[{"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/types\/trade-perspectives"}],"author":[{"embeddable":true,"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/users\/2"}],"version-history":[{"count":7,"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/trade-perspectives\/1430\/revisions"}],"predecessor-version":[{"id":1473,"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/trade-perspectives\/1430\/revisions\/1473"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/media\/1435"}],"wp:attachment":[{"href":"https:\/\/www.fratinivergano.eu\/en\/wp-json\/wp\/v2\/media?parent=1430"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}