{"id":26328,"date":"2025-05-06T09:04:25","date_gmt":"2025-05-06T07:04:25","guid":{"rendered":"https:\/\/www.chemsafe-consulting.com\/?p=26328"},"modified":"2025-05-06T09:04:25","modified_gmt":"2025-05-06T07:04:25","slug":"april-regulatory-updates-3","status":"publish","type":"post","link":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/","title":{"rendered":"April Regulatory Updates"},"content":{"rendered":"

Food:<\/u><\/strong><\/h4>\n
Safe2Eat 2025: EFSA relaunches campaign to boost EU consumer confidence in food safety<\/strong><\/h6>\n

Fifth year of the campaign, now in 23 countries<\/strong>
\nThe European Food Safety Authority (EFSA) has launched the 2025 edition of its Safe2Eat<\/em> campaign to continue strengthening consumer confidence in food safety. Now in its fifth year, the campaign has expanded its reach to 23 countries, five more than in 2024, with the goal of helping more Europeans make informed food choices based on reliable, science-based information.<\/p>\n

Record impact in 2024<\/strong>
\nThe 2024 edition of Safe2Eat reached over 45% of its target audience across Europe\u2014more than double the 2023 figure (19%). Through social media engagement, influencer collaborations, and targeted media campaigns, EFSA reached over 50 million Europeans. The campaign also had a measurable influence on consumer behavior, with more people saying they now consider food safety when shopping and find food safety information easier to understand.<\/p>\n

Key goals for 2025<\/strong>
\nThis year, Safe2Eat will:<\/p>\n

    \n
  • Further expand in 23 countries, including five new participants;<\/li>\n
  • Address key consumer concerns such as the role of science in food safety, clear food labeling, and food waste reduction;<\/li>\n
  • Improve access to food safety information through tailored, easy-to-understand resources for different age groups and cultural backgrounds.<\/li>\n<\/ul>\n

    EFSA\u2019s commitment<\/strong>
    \nEFSA\u2019s acting Executive Director, Bernhard Url, stated: \u201cConsumers face a complex food landscape, and it\u2019s crucial they feel empowered to make informed choices. Safe2Eat bridges the gap between food safety science and everyday decisions.\u201d<\/p>\n

    How to get involved<\/strong>
    \nSafe2Eat initiatives will run across the EU throughout the year. Consumers can access educational content via the official campaign website and engage on social media using the hashtag #Safe2EatEU<\/strong>.<\/p>\n

     <\/p>\n

    EFSA Updates Botanicals Compendium to Support Safer Food Supplements<\/strong><\/h6>\n

    Overview<\/strong>
    \nBotanicals\u2014plant-derived substances like ginseng or garlic\u2014are widely used in EU food supplements and often marketed as natural products. However, concerns about their safety persist due to possible contamination or high levels of active substances.<\/p>\n

    New Database Edition Released<\/strong>
    \nEFSA has released the 4th edition of its Compendium of Botanicals<\/em>, now covering 2,701 plant species and listing 1,538 naturally occurring substances of potential concern. The tool supports safety assessments by providing toxicological data from scientific literature and models. It is not meant to determine risk but to help identify potential hazards.<\/p>\n

    EFSA’s Safety Framework<\/strong>
    \nSince 2004, EFSA has developed scientific tools and guidance to assess botanical safety. The toolkit includes:<\/p>\n

      \n
    • A guidance document for risk assessment,<\/li>\n
    • Case study reports,<\/li>\n
    • A regularly updated compendium.<\/li>\n<\/ul>\n

      Key Milestones<\/strong>
      \nRecent developments include:<\/p>\n

        \n
      • 2024<\/strong>: New working group launched to track emerging risks in food supplements.<\/li>\n
      • 2023-2022<\/strong>: Safety assessments for berberine, fennel, and hydroxycitric acid initiated.<\/li>\n
      • 2016-2009<\/strong>: Compendium expanded and improved; safety guidance published.<\/li>\n<\/ul>\n

        Regulatory Context<\/strong>
        \nThe EU does not centrally regulate botanicals in food; Member States oversee this area, following general food safety laws. Botanicals may be subject to additional EFSA review under EU novel food or additive regulations if safety concerns arise.<\/p>\n

         <\/p>\n

        Re-evaluation of Acesulfame K Completed<\/strong><\/h6>\n

        EFSA has completed its latest re-evaluation of the artificial sweetener acesulfame K (E 950), widely used in food and beverages. The re-assessment is part of the EU\u2019s program to review additives approved before 2009 under Regulation (EU) No 257\/2010.<\/p>\n

        Safety Confirmed at Current Levels<\/strong><\/p>\n

        The Panel on Food Additives and Flavourings (FAF) confirmed that acesulfame K is safe for human consumption at current exposure levels. The previously established acceptable daily intake (ADI) of 9 mg\/kg body weight per day remains valid.<\/p>\n

        Comprehensive Toxicological Review<\/strong><\/p>\n

        The panel reviewed a wide range of data including studies on genotoxicity, carcinogenicity, reproductive and developmental toxicity, as well as available human studies. No evidence of health concerns was found.<\/p>\n

        Exposure Estimates and Use Levels<\/strong><\/p>\n

        Using updated food consumption data across all age groups, EFSA concluded that estimated dietary exposure to acesulfame K remains below the ADI in all population groups, even under conservative scenarios.<\/p>\n

        Regulatory Context and Next Steps<\/strong><\/p>\n

        This opinion supports the continued use of acesulfame K in foods as authorised by EU legislation. The findings will inform future regulatory decisions and risk management measures related to food additives.<\/p>\n

        Inizio modulo<\/p>\n

         <\/p>\n

        REACH:<\/u><\/strong><\/h4>\n
        EU Moves Forward on PFAS Ban in Firefighting Foams<\/strong><\/h6>\n

        Revised Draft Regulation Under Review<\/strong>
        The European Commission<\/strong> has submitted a revised draft regulation<\/strong> to restrict all PFAS<\/strong> in firefighting foams<\/strong>. The proposal would ban the placing on the market, use, and export<\/strong> of firefighting foams containing PFAS above 1ppm<\/strong>, introducing stricter control across sectors.<\/p>\n

        Key Features of the Draft<\/strong><\/p>\n

          \n
        • General 5-year transition period<\/strong> for most sectors<\/li>\n
        • Sector-specific transition periods<\/strong> to allow for adaptation<\/li>\n
        • Clarified definitions<\/strong> of firefighting foam and its various forms<\/li>\n
        • Review clause<\/strong>: The Commission must reassess the derogation for cleaned equipment<\/strong> within five years<\/li>\n
        • Substance management plans<\/strong>: Retention period extended to 15 years<\/strong>, with more detailed requirements, including substitution strategies<\/strong><\/li>\n<\/ul>\n

          Next Steps<\/strong>
          The draft was discussed at the upcoming REACH Committee meeting<\/strong> on 29 April<\/strong>, where national experts evaluated the proposal. If a qualified majority<\/strong> supports the measure, the Commission is expected to proceed to a formal vote.<\/p>\n

          Implementation Timeline<\/strong>
          Adoption of the regulation is anticipated in the second quarter of 2025<\/strong>, marking a significant move in the EU\u2019s broader strategy to phase out PFAS<\/strong> and limit their environmental and health impacts.<\/p>\n

          \u00a0<\/strong><\/h3>\n
          ECHA\u2019s RAC Classifies Silver Nitrate as Suspected Carcinogen<\/strong><\/h6>\n

          New Classification Agreed by RAC<\/strong>
          ECHA\u2019s Risk Assessment Committee (RAC)<\/strong> has concluded that silver nitrate<\/strong> should be classified as a category 2 carcinogen<\/strong>, meaning it is suspected of causing cancer<\/strong>. The decision follows the late inclusion of a significant industry study<\/strong> on carcinogenicity, which RAC accepted for review even after the formal consultation period had closed.<\/p>\n

          Wider Classification Scope<\/strong>
          At its November plenary<\/strong>, RAC also agreed to classify silver nitrate as:<\/p>\n

            \n
          • Category 1B reprotoxicant<\/strong> (may damage fertility or the unborn child)<\/li>\n
          • Category 2 mutagen<\/strong> (suspected of causing genetic defects)<\/li>\n
          • STOT RE<\/strong> (specific target organ toxicity from repeated exposure), particularly affecting the nervous system<\/strong><\/li>\n<\/ul>\n

            These classifications align with industry self-classification<\/strong> of similar silver compounds, according to Eurometaux\u2019s Violaine Verougstraete<\/strong>.<\/p>\n

            Basis for Classification<\/strong>
            The reclassification stems from read-across evidence<\/strong> based on the toxic silver ion<\/strong>, which is common across many silver-containing substances. ECHA\u2019s previous review of 43 silver compounds<\/strong>\u2014mostly used as biocides<\/strong>\u2014supports this shared mode of toxicity. While the current assessment focuses on ionic silver<\/strong>, silver nanoparticles<\/strong> may pose additional risks due to particle-specific effects<\/strong> like inflammation and cellular uptake.<\/p>\n

            Industry Carcinogenicity Study<\/strong>
            The European Precious Metals Federation (EPMF)<\/strong> submitted a combined chronic toxicity and carcinogenicity study on silver acetate<\/strong>, conducted on rats under OECD guideline 453<\/strong>, which showed kidney tumor development<\/strong>.
            Sweden, in its review, also flagged endocrine tissue effects<\/strong> that may be relevant under the emerging endocrine disruption hazard class<\/strong>, even if they didn\u2019t meet formal carcinogenicity criteria.<\/p>\n

            Next Steps<\/strong>
            While RAC\u2019s full opinion has yet to be published, its conclusions mark a critical step toward harmonised classification and labelling (CLH)<\/strong> of silver nitrate under the CLP Regulation<\/strong>. If adopted, this could impact regulatory status and market use of silver-containing products across the EU.<\/p>\n

             <\/p>\n

            ECHA Proposes EU Ban on Chromium Trioxide Substances by 2028<\/strong><\/h6>\n

            Comprehensive Cr(VI) Ban Proposed<\/strong>
            \nECHA has proposed a wide-reaching restriction<\/strong> on all 11 chromium trioxide (Cr(VI)) substances<\/strong> currently under REACH authorisation. The ban would replace existing authorisation requirements and come into effect across the European Economic Area (EEA) in 2028<\/strong>. A six-month public consultation will open on 18 June<\/strong>, followed by a review by ECHA\u2019s scientific committees.<\/p>\n

            Health and Environmental Risks<\/strong>
            \nCr(VI) substances are among the most potent workplace carcinogens<\/strong>, posing serious risks to workers and local communities. ECHA estimates the proposed restriction could prevent up to 195 cancer cases annually<\/strong> and 17 tonnes of Cr(VI) releases<\/strong> into the environment, offering total benefits worth up to \u20ac1.07 billion over 20 years<\/strong>.<\/p>\n

            Scope and Exemptions<\/strong>
            \nThe restriction would cover mixtures containing Cr(VI), though not the manufacture of the substances themselves. Certain industrial uses would be exempt<\/strong> if strict exposure and emission thresholds are met, including:<\/p>\n

              \n
            • Formulation of mixtures<\/li>\n
            • Electroplating on plastic and metal substrates<\/li>\n
            • Use of primers and slurries<\/li>\n
            • Surface treatments<\/li>\n
            • Functional additives and process aids<\/li>\n<\/ul>\n

              Three Restriction Options<\/strong>
              \nECHA proposed three restriction options (RO1\u2013RO3)<\/strong> with varying occupational and environmental limit values<\/strong>:<\/p>\n

                \n
              • RO1<\/strong>: Most lenient, aligned with current BOEL (5 \u00b5g\/m\u00b3)<\/li>\n
              • RO2<\/strong>: Moderate, with lower exposure thresholds<\/li>\n
              • RO3<\/strong>: Strictest, down to 0.1 \u00b5g\/m\u00b3<\/li>\n<\/ul>\n

                ECHA favors RO1 and RO2 due to their feasibility and cost-effectiveness<\/strong> for industry.<\/p>\n

                From Authorisation to Restriction<\/strong>
                \nThis shift follows a 2023 EU court ruling<\/strong> that annulled an upstream Cr(VI) authorisation, prompting the Commission to seek a more streamlined solution. Placing Cr(VI) under restriction avoids thousands of individual authorisation requests and eases pressure on REACH resources<\/strong>.<\/p>\n

                Since 2015, ECHA has received hundreds of applications<\/strong> for Cr(VI) uses\u2014far more than anticipated. Despite decreasing use volumes, there are still nearly 4,000 notified uses<\/strong> across sectors like automotive, chemicals, transport, and packaging<\/strong>.<\/p>\n

                Challenge of Substitution<\/strong>
                \nCurrently, no direct substitutes<\/strong> match Cr(VI)\u2019s performance. Alternatives either lack technological maturity<\/strong>, are less effective<\/strong>, or still pose health risks<\/strong>. Adoption would require major investment<\/strong> and could raise production costs by 10\u201320%<\/strong>. ECHA also warns that imports of Cr(VI)-treated goods<\/strong> could undermine the effectiveness of the restriction unless regulated.<\/p>\n

                Next Steps<\/strong>
                \nIf adopted, companies will face a difficult choice: invest in compliance or cease production<\/strong>. The 18-month transition<\/strong> and a restriction effective from 2028 aim to give industry time to adapt.<\/p>\n

                This move marks a major shift in EU chemicals policy<\/strong>, reinforcing the Commission\u2019s intent to reserve authorisation for high-volume substances with limited use cases<\/strong>, while moving widely used hazardous substances to restriction<\/strong>.<\/p>\n

                 <\/p>\n

                 <\/p>\n

                Biocides:<\/u><\/strong><\/h4>\n
                ECHA and EFSA Call for Unified Chemicals Data Platform to Streamline Biocide and Pesticide Assessments<\/strong><\/h6>\n

                Push for Centralized Data Sharing<\/strong>
                At ECHA\u2019s Biocides Stakeholders\u2019 Workshop on 29 April<\/strong>, ECHA and EFSA<\/strong> jointly called for the creation of a common EU chemicals data platform<\/strong> to overcome legal barriers and resource bottlenecks<\/strong> that currently hinder effective cooperation on biocide and pesticide assessments<\/strong>.<\/p>\n

                The proposal aligns with the European Commission\u2019s “One Substance, One Assessment” (OSOA)<\/strong> strategy, aiming to centralize data across 70 EU laws<\/strong>. The platform would allow cross-agency access to information on shared substances, reducing duplicate work and promoting consistency.<\/p>\n

                Efficiency and Animal Testing Reduction<\/strong>
                EFSA\u2019s pesticides unit head, Manuela Tiramani<\/strong>, stressed that unified access to chemical data “makes full sense,” as it would save time, reduce costs, avoid duplicate animal testing<\/strong>, and improve assessment quality. Roughly 30% of biocidal substances<\/strong> are also regulated as plant protection products, making overlap common.<\/p>\n

                Barriers and Inconsistencies<\/strong>
                Despite existing cooperation, different datasets, applicants, and timelines<\/strong> under the Biocidal Products Regulation (BPR)<\/strong> and Plant Protection Products Regulation (PPPR)<\/strong> often lead to inconsistent conclusions<\/strong> for the same substance. Tiramani noted that diverging methodologies<\/strong> between ECHA and EFSA create challenges for both agencies and applicants.<\/p>\n

                Pilot Efforts and Setbacks<\/strong>
                The agencies attempted to coordinate evaluations through a pilot OSOA project starting with tebuconazole<\/strong>, but it was dropped due to external delays<\/strong> and uneven progress<\/strong>. Other joint evaluations included substances like dinotefuran<\/strong>, sulfuryl fluoride<\/strong>, and cypermethrin<\/strong>, with shared committee participation.<\/p>\n

                Resource Constraints Persist<\/strong>
                Both BPR and PPPR suffer from staff shortages<\/strong>, low-quality dossiers<\/strong>, and increasing demands, leading to assessment delays of up to eight years<\/strong>. Although the Chemicals Strategy for Sustainability (CSS)<\/strong> promised improvements, Tiramani warned that the EU\u2019s current regulatory framework is still too fragmented<\/strong> to fully support OSOA.<\/p>\n

                A Call to Align Frameworks<\/strong>
                Despite challenges, EFSA and ECHA urged regulators to push boundaries<\/strong> within legal limits, calling for:<\/p>\n

                  \n
                • Joint mandates<\/strong> for assessments<\/li>\n
                • Harmonized guidance documents<\/strong><\/li>\n
                • Greater regulatory coordination<\/strong> between agencies<\/li>\n<\/ul>\n

                  The proposed platform, strongly backed by the European Parliament, remains a key step toward achieving coherent, efficient chemical risk assessments<\/strong> across the EU.<\/p>\n","protected":false},"excerpt":{"rendered":"

                  Food: Safe2Eat 2025: EFSA relaunches campaign to boost EU consumer confidence in food safety Fifth year of the campaign, now in 23 countries The European Food Safety Authority (EFSA) has launched the 2025 edition of its Safe2Eat campaign to continue strengthening consumer confidence in food safety. Now in its fifth year, the campaign has expanded its reach to 23 countries, five more than in 2024, with the goal of helping more Europeans make informed food choices based on reliable, science-based information. Record impact in 2024 The 2024 edition of Safe2Eat reached over 45% of its target audience across Europe\u2014more than double the 2023 figure (19%). Through social media engagement, influencer collaborations, and targeted media campaigns, EFSA reached over 50 million Europeans. The campaign also had a measurable influence on consumer behavior, with more people saying they now consider food safety when shopping and find food safety information easier to understand. Key goals for 2025 This year, Safe2Eat will: Further expand in 23 countries, including five new participants; Address key consumer concerns such as the role of science in food safety, clear food labeling, and food waste reduction; Improve access to food safety information through tailored, easy-to-understand resources for different age…<\/p>\n","protected":false},"author":2,"featured_media":26329,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53,100],"tags":[],"class_list":["post-26328","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-regulatory-updates"],"yoast_head":"\nApril Regulatory Updates - ChemSafe<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"April Regulatory Updates\" \/>\n<meta property=\"og:description\" content=\"Food: Safe2Eat 2025: EFSA relaunches campaign to boost EU consumer confidence in food safety Fifth year of the campaign, now in 23 countries The European Food Safety Authority (EFSA) has launched the 2025 edition of its Safe2Eat campaign to continue strengthening consumer confidence in food safety. Now in its fifth year, the campaign has expanded its reach to 23 countries, five more than in 2024, with the goal of helping more Europeans make informed food choices based on reliable, science-based information. Record impact in 2024 The 2024 edition of Safe2Eat reached over 45% of its target audience across Europe\u2014more than double the 2023 figure (19%). Through social media engagement, influencer collaborations, and targeted media campaigns, EFSA reached over 50 million Europeans. The campaign also had a measurable influence on consumer behavior, with more people saying they now consider food safety when shopping and find food safety information easier to understand. 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Now in its fifth year, the campaign has expanded its reach to 23 countries, five more than in 2024, with the goal of helping more Europeans make informed food choices based on reliable, science-based information. Record impact in 2024 The 2024 edition of Safe2Eat reached over 45% of its target audience across Europe\u2014more than double the 2023 figure (19%). Through social media engagement, influencer collaborations, and targeted media campaigns, EFSA reached over 50 million Europeans. The campaign also had a measurable influence on consumer behavior, with more people saying they now consider food safety when shopping and find food safety information easier to understand. Key goals for 2025 This year, Safe2Eat will: Further expand in 23 countries, including five new participants; Address key consumer concerns such as the role of science in food safety, clear food labeling, and food waste reduction; Improve access to food safety information through tailored, easy-to-understand resources for different age...","og_url":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/","og_site_name":"ChemSafe","article_published_time":"2025-05-06T07:04:25+00:00","og_image":[{"width":1280,"height":1024,"url":"https:\/\/www.chemsafe-consulting.com\/wp-content\/uploads\/2025\/05\/April-Regulatory-Updates.png","type":"image\/png"}],"author":"Gabriele Pincitore","twitter_card":"summary_large_image","twitter_misc":{"Scritto da":"Gabriele Pincitore","Tempo di lettura stimato":"10 minuti"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/#article","isPartOf":{"@id":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/"},"author":{"name":"Gabriele Pincitore","@id":"https:\/\/www.chemsafe-consulting.com\/it\/#\/schema\/person\/ef0ec20da44f19fd3ed5eb9334b54119"},"headline":"April Regulatory Updates","datePublished":"2025-05-06T07:04:25+00:00","mainEntityOfPage":{"@id":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/"},"wordCount":1923,"publisher":{"@id":"https:\/\/www.chemsafe-consulting.com\/it\/#organization"},"image":{"@id":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/#primaryimage"},"thumbnailUrl":"https:\/\/www.chemsafe-consulting.com\/wp-content\/uploads\/2025\/05\/April-Regulatory-Updates.png","articleSection":["Blog","Regulatory Updates"],"inLanguage":"it-IT"},{"@type":"WebPage","@id":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/","url":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/april-regulatory-updates-3\/","name":"April Regulatory Updates - 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