Sebastian Pitucha

📢 👁 European Chemicals Agency's Inspection: 35% of Safety Data Sheets fail to meet REACH and CLP Standards. 🇪🇸 Spanish version: Inspección FDS de la ECHA concluye que el 35% de las Fichas de Datos de Seguridad no cumplen con REACH y CLP.https://https://lnkd.in/dbeS62hp 📊 Non-compliance rate: A concerning 35% of the inspected SDS were found to be non-compliant 🔗 Supply chain compliance: The supply chain for SDS appears to be functioning effectively, with suppliers providing SDS to recipients in 96% of cases 🆕 New information requirements: Significant challenges were observed in providing information on nanoforms and endocrine-disrupting properties. 67% of SDS lacked information on nanoforms, and 48% were deficient in data on endocrine-disrupting properties ✅ Data quality issues: A notable 27% of the SDS exhibited data quality issues and 18% of the SDS lacked the required exposure scenarios Do you need to prepare or assess the quality of your SDS? Nordiik can help, contact us! For more details on the inspection findings and the necessary steps, visit our blog 👇🏼 #SDS #MSDS #EU_REACH #EU_CLP #REACH #CLP #chemicals #regulatory #SaferChemicals #industry https://lnkd.in/dcgkiguT

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ECHA guidance on the application of the CLP criteria ⚠️ ECHA has updated its guidance on the application of Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging (CLP) of substances and mixtures. The most notable change to Part 3, which focuses on human health hazards, is the addition of guidance on Endocrine Disruption (ED). This follows the introduction, in 2023, of the new human health hazard classes, ED HH 1 (may cause endocrine disruption in humans) and ED HH 2 (suspected of causing endocrine disruption in humans). The new ED classification criteria require evidence on three elements, namely adverse effects, endocrine activity, and biological plausibility. The (preliminary) classification of a substance as ED HH 2 could be seen relatively frequently, resulting in a significant amount of subsequent work. For example, where ED-related adverse effects are observed in the presence of co-occurring toxicity, the guidance states that the former must be demonstrated to be solely the consequence of the latter to justify that no classification is needed. Furthermore, there is no dose level above which the occurrence of an ED-related adverse effect is outside the criteria which lead to classification. https://lnkd.in/ggk7uu9 This is from the December edition of our publication, "Toxicology and Regulatory News". If you'd like to receive FREE monthly editions of TRN, please get in touch. #Toxicology #ScienceNews #CatchUp #Science #WhatsNewInTox #ToxLatestUpdates #ToxNews #ECHA #CLP #CLPCriteria #EndocrineDisruption

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Don't Let Internal Audits Be a Burden: Unlock Their True Value Think internal audits are just a compliance exercise? Think again! Our latest article explains how ISO internal audits are a powerful tool for continuous improvement and organizational excellence in laboratories: https://buff.ly/3vUEJ3T Key takeaways: ✔️ Identify risks and non-conformities early before they become major problems. ✔️ Gain valuable insights for process optimisation through independent, data-driven assessments. ✔️ Boost confidence by ensuring procedures are effectively implemented. Ready to transform internal audits into a valuable asset? Read the full article! #ISO #Audits #lifescience #pharma

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Talc (without asbestos) in personal care and pharmaceutical products will now considered as category 1B carcinogen through all routes of exposure by ECHA. This Wednesday ECHA RAC concluded based on: 1.There is sufficient evidence that talc can induce tumors at different sites (non-systemic at port-of-entry/after translocation via different routes of exposure) and in different species based on limited evidence in animals (lung tumors in female rats) and limited evidence in humans (ovarian tumors in women). 2. The analogous mode of action for both tumor types (lung tumors in rats and ovarian tumors in women) is biologically plausible and therefore supports combined weighting of the carcinogenicity evidence. 3. The experimental animal data with inferred causality (talc being the causative agent), supports causal interpretation of ovarian cancer studies in humans. There exists one school of thought that- Talc powder contains contaminant asbestos, which is a culprit for cancer. IARC has classified only talc with asbestos as carcinogen but not pure talc. Interestingly, now ECHA RAC considers talc without asbestos as Carcinogen. For more info for the interest of public health. Read below: https://lnkd.in/gVVfnMN8 ECHA RAC https://lnkd.in/gJaJfms2 Image credit-DrugWatch #talc #cancer

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New Post: Climate change revisions to ISO standards – Certification Europe - https://lnkd.in/eWfdapTP New amendments to ISO international standards On 23rd February 2024, the International Organisation for Standardisation (ISO) made significant amendments to several widely used standards concerning climate change. Read on to find out what these changes are and what they mean for your organisation.   Which standards are affected? These amendments impact a variety of ISO standards, including: ISO 9001 ISO 14001 ISO 27001 ISO 45001 ISO 22301 ISO 20000-1 ISO 50001   What’s new in the amendments? The amendments introduce two key additions related to climate change: Organisations are now required to assess whether climate change is a relevant issue impacting their management system, as outlined in section 4.1 of these standards. A new note in section 4.2 highlights that relevant interested parties may have requirements related to climate change.   Addressing your frequently asked questions: Please check the following common questions and answers regarding these amendments. Why were these requirements added? ISO incorporated these amendments to align with the London Declaration on Climate Change, emphasising the importance of considering climate change’s impact on organisational management systems. What does this mean for a certified organisation? Certified organisations must review whether climate change affects their management systems, potentially leading to significant adjustments. What are the expectations? Organisations are expected to thoroughly analyse internal and external issues, as well as the needs and expectations of relevant interested parties, to address any concerns about their management systems. Do these amendments change the intent of the requirements? No, these amendments simply highlight the potential relevance of climate change within management systems. Transition timing and audits There’s no specified transition timeline; the requirements are effective immediately. While auditors may ask about these new requirements, they won’t heavily focus on them during audits. Further resources and support You can obtain a copy of the amendments from your local standards organisation or via this link. Additionally, for those concerned about climate change’s impact on their organisation, the ISO.org website offers a downloadable Climate Action Toolkit, providing valuable information to help you consider how climate change might be a factor for your organisation.   Contact us for assistance If you have more questions or need assistance navigating these changes, please don’t hesitate to reach out to us at [email protected] or call us on +353 1 270 7973. Source link QHSE Management

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[Notified Bodies] Code of Conduct under Regulations (EU) 2017/745 and (EU) 2017/746 The update reflects the current applicable legislation and guidance documents. Only aspects of conformity assessment that benefit from some detail to enhance consistency are covered. All references to obsolete legislation (93/42/EEC, 90/384/EEC and 98/79/EC) are removed. References to guidance, standards and mandatory documents from the International Accreditation Forum (IAF) are updated.

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The latest edition of ISO 11040-4:2024 introduces crucial updates that impact quality management, syringe design, performance testing, and sub-assembly guidelines for prefilled syringes. For manufacturers and quality assurance professionals, staying informed about these changes is essential to maintaining compliance and delivering safe, reliable products. Key updates to ISO 11040-4:2024 include: - Formal Quality Management System (QMS) requirements - New specifications for staked needle syringes - Expanded testing guidelines for non-lubricated syringes These updates focus on quality, precision, and stronger collaboration, helping manufacturers stay compliant while delivering reliable, high-quality syringes. Please read our latest blog for a more detailed breakdown of these changes. https://lnkd.in/gXrQnqbG If you need support with ISO 11040 testing or any upcoming projects, feel free to reach out to one of our engineers at DDL. #MedicalDevices #ISO11040 #PrefilledSyringes #QualityManagement #Compliance #MedTech #Pharma #RegulatoryUpdates

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🔔  𝐍𝐞𝐰 𝐒𝐕𝐇𝐂 𝐚𝐝𝐝𝐞𝐝 𝐭𝐨 𝐑𝐄𝐀𝐂𝐇 𝐂𝐚𝐧𝐝𝐢𝐝𝐚𝐭𝐞 𝐋𝐢𝐬𝐭! ECHA has recently included 𝐓𝐫𝐢𝐩𝐡𝐞𝐧𝐲𝐥 𝐏𝐡𝐨𝐬𝐩𝐡𝐚𝐭𝐞 (𝟏𝟏𝟓-𝟖𝟔-𝟔) in the REACH Candidate List of Substances of Very High Concern (SVHCs). This means articles containing this substance above 0.1% w/w concentration are now subject to SCIP database reporting requirements. 📖𝐄𝐱𝐚𝐦𝐩𝐥𝐞𝐬 𝐨𝐟 𝐮𝐬𝐞𝐬: This substance is used as a flame retardant and plasticiser in polymer formulations, adhesives and sealants. 🚗🚕🚙𝐈𝐌𝐃𝐒 (𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐌𝐚𝐭𝐞𝐫𝐢𝐚𝐥 𝐃𝐚𝐭𝐚 𝐒𝐲𝐬𝐭𝐞𝐦) 𝐮𝐬𝐞𝐫𝐬 𝐰𝐡𝐨 𝐫𝐞𝐩𝐨𝐫𝐭 𝐒𝐂𝐈𝐏 𝐝𝐢𝐫𝐞𝐜𝐥𝐭𝐲 𝐯𝐢𝐚 𝐈𝐌𝐃𝐒 𝐬𝐡𝐨𝐮𝐥𝐝 𝐛𝐞 𝐚𝐰𝐚𝐫𝐞 that the system will not automatically flag this new SVHC until DXC Technology, which manages IMDS, updates the SCHC (Substances of Concern for the Health of Children) List. IMDS users will need to either wait for this update or manage SCIP reporting manually through the IUCLID system and ECHA Submission Portal if they need to act immediately. 📚 For the latest on this update, read ECHA’s announcement.👇 https://lnkd.in/eNC3ShVK #IMDS #REACH #SCIP #Compliance #SubstancesOfConcern #SVHC

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🔔Update: Triphenyl phosphate (CAS 115-86-6) was added to the REACH Candidate List of SVHCs and was marked SVHC in IMDS. #IMDS #REACH #SCIP #Compliance #SubstancesOfConcern #SVHC

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Do you know what nonconformities https://lnkd.in/daNJMcBB are and how they impact your business? From understanding their root causes to implementing strategies for prevention, we’ve got you covered! Discover how to ensure conformity and elevate your quality management processes today. #QualityManagement #ISO9001 #ContinuousImprovement

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"CLP Labelling (EU & UK)" a very popular training course from the Chemical Hazards Communication Society - CHCS. Delivered live online on 16 & 17 December 2024. Only £300 (+VAT). This module covers the label elements including pictograms, signal words, hazard statements and precautionary statements. Delegates will be shown how to pull these elements together into a label which is compliant in content and format. The course will also cover rules for affixing of labels, language, tactile warning devices, updating of labels and packaging requirements. This training course is mainly aimed at those responsible for ensuring that supply labeling is compliant and Safety Data Sheet writers. For more details or to reserve your place, please visit: https://lnkd.in/eJRFyH_t #chemicalsafety #eu #clp #ghs #safetydatasheet #sds #msds #chcs #chemicalhazards

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Ensure compliance with CLP Article 40: suppliers must notify hazardous substances within 1 month of market placement, including detailed substance identity and classification info. Learn more > https://ow.ly/wazg50ThekI #CLP #EU #ChemicalCompliance #ChemicalHazard #Compliance #Regulation #ChemicalIndustry

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This article covers two specific elements of an effective Quality Management System (QMS) change control management process with which manufacturers continue to have compliance concerns including:   • Change Identification / Awareness • Change Impact Assessment To learn more about QMS requirements and ensure compliance, click here: https://bit.ly/3WgvbdU #QMS #ISO13485 #MedEnvoy

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Updated guidance on new CLP criteria: European Chemicals Agency has updated guidance on applying the classification, labelling and packaging (CLP) regulation which can be accessed here: https://lnkd.in/ggk7uu9 To find out more information on the new guidance, please follow the ECHA webinar: https://lnkd.in/dMTtwWKX

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ISO 9001 Amendment: Guidance on auditing Climate Change issues in ISO 9001 - https://lnkd.in/dYvJ4aK9

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