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		<title>PFAS Risk Assessment and Compliance: From the future REACH Restriction to Article 5(5) of Regulation (EU) 2025/40 (PPWR)</title>
		<link>https://carmensorice.com/en/blog-en/pfas-risk-assessment-and-compliance-from-the-future-reach-restriction-to-article-55-of-regulation-eu-2025-40-ppwr/</link>
		
		<dc:creator><![CDATA[wfbadmin]]></dc:creator>
		<pubDate>Tue, 03 Mar 2026 14:39:37 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[EU chemicals regulation]]></category>
		<category><![CDATA[food contact materials]]></category>
		<category><![CDATA[packaging compliance]]></category>
		<category><![CDATA[PFAS]]></category>
		<category><![CDATA[PPWR 2025/40]]></category>
		<category><![CDATA[REACH restriction]]></category>
		<guid isPermaLink="false">https://carmensorice.com/news-carmen-en/pfas-risk-assessment-and-compliance-from-the-future-reach-restriction-to-article-55-of-regulation-eu-2025-40-ppwr/</guid>

					<description><![CDATA[<p>L'articolo <a href="https://carmensorice.com/en/blog-en/pfas-risk-assessment-and-compliance-from-the-future-reach-restriction-to-article-55-of-regulation-eu-2025-40-ppwr/">PFAS Risk Assessment and Compliance: From the future REACH Restriction to Article 5(5) of Regulation (EU) 2025/40 (PPWR)</a> proviene da <a href="https://carmensorice.com/en/">Carmen Sorice Regulatory Affairs</a>.</p>
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	<h2>What are PFAS and why do they represent a risk?</h2>
<p>Per- and poly-fluoroalkyl substances (<strong>PFAS</strong>) constitute a vast family of thousands of synthetic chemicals characterized by a completely (<strong>per</strong>) or partially (<strong>poly</strong>) fluorinated carbon chain. This structure gives them extraordinary properties, such as water and oil repellency and thermal resistance, making them ideal for surface treatments of paper and cardboard since the 1950s. However, they are known as &#8220;<strong>forever chemicals</strong>&#8221; due to their extreme stability, which makes them resistant to degradation and capable of accumulating in the environment and in organisms.<br />Scientific concern is supported by precise evidence: in 2023, the <strong>IARC</strong> (<em>International Agency for Research on Cancer</em>) elevated the hazard level of <strong>PFOA</strong> to <strong>&#8220;certainly carcinogenic to humans&#8221; (Group 1)</strong>, while <strong>EFSA</strong> (<em>European Food Safety Authority</em>) in 2020 established a very restrictive tolerable weekly intake (<strong>TWI</strong>) for the sum of four key PFAS (<strong>PFOA, PFOS, PFNA, PFHxS</strong>), noting that the exposure of part of the European population already exceeds these limits (4.4 ng/kg of body weight per week).</p>
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	<h3>ECHA&#8217;s Universal Restriction Proposal (UPR)</h3>
<p>The ECHA (<em>European Chemicals Agency</em>) <em>Background Document</em> clarifies the scope of the REACH restriction proposal, officially presented in January 2023 by the authorities of five Member States: <strong>Germany, the Netherlands, Denmark, Norway, </strong>and <strong>Sweden</strong>. The goal is to restrict approximately <strong>10,000 </strong>PFAS substances, preventing their release throughout the entire product life cycle.<br />Given the ubiquitous nature of these substances, the global restriction affects a very wide range of industrial sectors:</p>
<ul>
<li><strong>Textiles and Clothing:</strong> Technical fabrics and water-repellent treatments.</li>
<li>E<strong>lectronics and Semiconductors:</strong> Critical components for hardware and infrastructure.</li>
<li><strong>Transport (Automotive and Aerospace):</strong> Seals, cables, and hydraulic fluids.</li>
<li><strong>Energy:</strong> Solar panels and hydrogen technologies.</li>
<li><strong>Consumer Products:</strong> Non-stick cookware, cosmetics, and firefighting foams.</li>
<li><strong>FCM (Food Contact Materials):</strong> Barrier treatments for paper and cardboard, plastics, rubbers.</li>
</ul>
<p>It is important to emphasize that REACH is already intervening with concrete measures on specific subclasses. An example is <strong>Regulation (EU) 2024/2462</strong> which limits the use of <strong>perfluorohexanoic acid (PFHxA)</strong>, its salts and related substances (Entry 79 – Annex XVII). From <strong>October 10, 2026</strong>, the ban on placing on the market will take effect for various applications, including paper and cardboard in contact with food.</p>
<h4><strong>The regulatory precedent: Denmark and the Netherlands</strong></h4>
<p>It is essential to highlight that for cellulosic FCMs, the restriction path has already begun at the national level. <strong>Denmark</strong>, a pioneer in this field, introduced a ban on the use of PFAS in paper and cardboard materials in contact with food as early as July <strong>2020</strong>. Similarly, <strong>the Netherlands</strong> implemented specific restrictions in <strong>2022</strong> limiting the use of these substances in paper and cardboard.</p>
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	<h3>Restrictions of Regulation (EU) 2025/40 (PPWR)</h3>
<p>While the REACH process continues, the packaging sector already has its limits defined in the new <strong>Regulation (EU) 2025/40 (PPWR)</strong>. Article 5, Paragraph 5, stipulates that starting from <strong>August 12, 2026</strong>, food contact packaging cannot be placed on the market if it exceeds the following concentration limit values:</p>
<ul>
<li><strong>25 ppb (µg/kg)</strong> for individual PFAS measured by targeted analysis.</li>
<li><strong>250 ppb (µg/kg)</strong> for the sum of measured PFAS.</li>
<li><strong>50 ppm (mg/kg)</strong> for total PFAS content, including polymeric ones.</li>
</ul>
<p>The 50 ppm limit serves as a critical threshold for screening. If the total fluorine content exceeds 50 mg/kg, the manufacturer or importer must provide documentary evidence (or second-level analysis) demonstrating whether this value is attributable to PFAS or non-PFAS substances.</p>
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	<h3>Compliance Strategy and Supply Chain Management</h3>
<p>Compliance is no longer just a matter of laboratory testing, but of rigorous technical-regulatory management:</p>
<ul>
<li><strong>Supplier Audits:</strong> Identify intentional addition and the presence of precursors or processing aids (PPA &#8211; Polymer Processing Aids).</li>
<li><strong>Documentary Update:</strong> The technical file (Annex VII of the PPWR) must be integrated with objective evidence of compliance.</li>
<li><strong>Unintentional Contamination:</strong> Particular attention should be paid to cellulosic materials and <strong>Recommendation (EU) 2019/794</strong> on the risks of migration from cross-contamination or recycled paper.</li>
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	<p><strong>Conclusions</strong></p>
<p>The transition to &#8220;PFAS-free&#8221; materials represents a structural change for the entire supply chain. The technical complexity of these substances and their widespread presence necessitate an accurate mapping of materials and constant dialogue with raw material suppliers.<br />Anticipating the analysis of one&#8217;s packaging against the requirements of August 12, 2026, is not only an act of legal compliance but a necessary step to ensure product safety and transparency toward the consumer. In a constantly evolving regulatory context, the correct interpretation of technical data and the constant updating of technical files remain the pillars for effective and conscious risk management.</p>
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<p>L'articolo <a href="https://carmensorice.com/en/blog-en/pfas-risk-assessment-and-compliance-from-the-future-reach-restriction-to-article-55-of-regulation-eu-2025-40-ppwr/">PFAS Risk Assessment and Compliance: From the future REACH Restriction to Article 5(5) of Regulation (EU) 2025/40 (PPWR)</a> proviene da <a href="https://carmensorice.com/en/">Carmen Sorice Regulatory Affairs</a>.</p>
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		<title>Drinking Water: The Technical Innovations of Legislative Decree 102/2025</title>
		<link>https://carmensorice.com/en/news-en/new-rules-dlgs-102-2025-drinking-water/</link>
		
		<dc:creator><![CDATA[wfbadmin]]></dc:creator>
		<pubDate>Fri, 18 Jul 2025 20:36:43 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[D.lgs. 102/2025]]></category>
		<category><![CDATA[drinking water]]></category>
		<category><![CDATA[PFAS]]></category>
		<category><![CDATA[water regulation]]></category>
		<category><![CDATA[water safety]]></category>
		<category><![CDATA[water safety plans]]></category>
		<guid isPermaLink="false">https://carmensorice.com/news-carmen-en/drinking-water-the-technical-innovations-of-legislative-decree-102-2025/</guid>

					<description><![CDATA[<p>L'articolo <a href="https://carmensorice.com/en/news-en/new-rules-dlgs-102-2025-drinking-water/">Drinking Water: The Technical Innovations of Legislative Decree 102/2025</a> proviene da <a href="https://carmensorice.com/en/">Carmen Sorice Regulatory Affairs</a>.</p>
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	<p>On July 4, 2025, <strong>Legislative Decree 102/2025</strong> was published in the Official Gazette. It amends and supplements Legislative Decree 18/2023, which implements EU Directive 2020/2184 on the quality of water intended for human consumption.</p>
<p>This regulatory update, <strong>in force since July 19, 2025</strong>, introduces a series of technical and operational requirements that impose operators, local authorities, and service providers to comply with stricter standards for the protection of public health.</p>
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            <a href="https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua.webp" aria-label="D.lgs. 102/2025: Nuove Regole per la Qualità delle Acque Potabili in Italia" class="pp center" title="D.lgs. 102/2025: Nuove Regole per la Qualità delle Acque Potabili in Italia">
              <img decoding="async" class="img-with-animation skip-lazy" data-delay="0" height="1280" width="1920" data-animation="none" src="https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua.webp" alt="novità D.lgs. 102/2025 acque potabili" srcset="https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua.webp 1920w, https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua-300x200.webp 300w, https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua-1024x683.webp 1024w, https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua-768x512.webp 768w, https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua-1536x1024.webp 1536w, https://carmensorice.com/wp-content/uploads/2025/07/dispensatore-d-acqua-900x600.webp 900w" sizes="(max-width: 1920px) 100vw, 1920px" />
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	<h2>An integrated and risk-based management system</h2>
<p>The decree strengthens the risk-based management model already provided for by Legislative Decree 18/2023, extending it to the entire water supply chain, from the catchment point to the final user.<br />
By July 2027, local authorities must complete the mapping and assessment of catchment areas, while by January 2029, operators will be required to implement Water Safety Plans (WSPs) not only for the public network but also for internal distribution systems, such as those in hospitals, schools, and apartment buildings.</p>
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	<h2>New parameters and stricter controls</h2>
<p>The decree introduces significant updates to water quality limits, with new parameters and stricter reference values:<br />
• Turbidity: ≤ 0.3 NTU in 95% of samples, never exceeding 1 NTU</p>
<ul>
<li>Lead: gradual reduction to 5 µg/L</li>
<li>PFAS: threshold values defined for individual PFAS and their sum; inclusion of the TFA parameter (trifluoroacetic acid)</li>
<li>Legionella: mandatory systematic control in internal systems.</li>
</ul>
<p>Laboratories must adapt analytical methods by adopting more sensitive and accurate techniques, while operators must increase the frequency and scope of monitoring.</p>
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            <a href="https://carmensorice.com/wp-content/uploads/2025/07/bicchiere-acqua.webp" aria-label="D.lgs. 102/2025: Nuove Regole per la Qualità delle Acque Potabili in Italia" class="pp center" title="D.lgs. 102/2025: Nuove Regole per la Qualità delle Acque Potabili in Italia">
              <img decoding="async" class="img-with-animation skip-lazy" data-delay="0" height="1420" width="948" data-animation="none" src="https://carmensorice.com/wp-content/uploads/2025/07/bicchiere-acqua.webp" alt="novità D.lgs. 102/2025 acque potabili" srcset="https://carmensorice.com/wp-content/uploads/2025/07/bicchiere-acqua.webp 948w, https://carmensorice.com/wp-content/uploads/2025/07/bicchiere-acqua-200x300.webp 200w, https://carmensorice.com/wp-content/uploads/2025/07/bicchiere-acqua-684x1024.webp 684w, https://carmensorice.com/wp-content/uploads/2025/07/bicchiere-acqua-768x1150.webp 768w" sizes="(max-width: 948px) 100vw, 948px" />
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	<h2>Materials in contact with water: the ReMaF system is born</h2>
<p>One of the most relevant innovations concerns the safety of materials used in the water supply chain. The decree establishes the <strong>ReMaF </strong>system, a national register regulating the authorization of reagents, filtering materials, and devices used in water treatment.<br />
The goal is to prevent the release of harmful substances and preserve the organoleptic properties of water, imposing a rigorous certification and control process on manufacturers and suppliers.</p>
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	<h2>Water kiosks and domestic devices in the scope of application</h2>
<p>The scope of application is expanded to include water dispensing and treatment devices such as kiosks, water houses, and domestic treatment equipment.<br />
These systems must ensure compliance with quality parameters up to the point of use, with maintenance, monitoring, and transparent documentation obligations placed on the operators.</p>
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	<h2>Information obligations and sanctioning system</h2>
<p>The decree also strengthens information obligations toward citizens, promoting access to updated and understandable data on water quality, also through digital channels.</p>
<p>At the same time, a stricter sanctioning system is introduced, with fines of up to €30,000 for serious non-compliance, particularly regarding the implementation of Water Safety Plans.</p>
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            <a href="https://carmensorice.com/wp-content/uploads/2025/07/acqua-che-scorre-da-un-rubinetto.webp" aria-label="D.lgs. 102/2025: Nuove Regole per la Qualità delle Acque Potabili in Italia" class="pp center" title="D.lgs. 102/2025: Nuove Regole per la Qualità delle Acque Potabili in Italia">
              <img decoding="async" class="img-with-animation skip-lazy" data-delay="0" height="1076" width="1920" data-animation="none" src="https://carmensorice.com/wp-content/uploads/2025/07/acqua-che-scorre-da-un-rubinetto.webp" alt="novità D.lgs. 102/2025 acque potabili" srcset="https://carmensorice.com/wp-content/uploads/2025/07/acqua-che-scorre-da-un-rubinetto.webp 1920w, https://carmensorice.com/wp-content/uploads/2025/07/acqua-che-scorre-da-un-rubinetto-300x168.webp 300w, https://carmensorice.com/wp-content/uploads/2025/07/acqua-che-scorre-da-un-rubinetto-1024x574.webp 1024w, https://carmensorice.com/wp-content/uploads/2025/07/acqua-che-scorre-da-un-rubinetto-768x430.webp 768w, https://carmensorice.com/wp-content/uploads/2025/07/acqua-che-scorre-da-un-rubinetto-1536x861.webp 1536w" sizes="(max-width: 1920px) 100vw, 1920px" />
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	<h3><strong>Conclusions</strong></h3>
<p>The entry into force of Legislative Decree 102/2025 introduces stricter standards and an integrated vision that covers the entire supply chain, from catchment to tap. For professionals in the sector, this marks the beginning of a phase full of challenges, but also opportunities: it will be essential to update skills, adopt advanced technologies, and develop increasingly effective control systems.</p>
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<p>L'articolo <a href="https://carmensorice.com/en/news-en/new-rules-dlgs-102-2025-drinking-water/">Drinking Water: The Technical Innovations of Legislative Decree 102/2025</a> proviene da <a href="https://carmensorice.com/en/">Carmen Sorice Regulatory Affairs</a>.</p>
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