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Chemicals |
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12th adaption to CLP regulation published |
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In April the 12th adaptation to technical progress (ATP) to the CLP Regulation came into force. The adaption implements the sixth and seventh revised editions to the Globally Harmonised System (GHS) of Classification and Labelling in the EU. The adaptation includes changes in annexes to the CLP Regulation such as:
The rules are effective from 17 October 2020 but may be used for classification and labelling already now. View 12th adaption of the CLP Regulation in official EU languages For more information, please contact: Helle M. Andersen
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New Zealand changes for hazardous substances and waste |
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New rules have been enforced in New Zealand as of 1 June for hazard substances in class 6 (toxic) and class 8 (corrosive) and for handling of hazardous waste. Class 6 and 8 substances
Read more on WorkSafes hjemmeside, including a quick guide to class 6 and 8 substances. Hazardous waste
For more information, please contact: Ilaria de Rosa Carstensen
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GHS – new revision end of 2019 |
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The eighth revision of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) is expected to be published by the end of 2019. Below we list some of the main changes. Hazard classes and hazard statements:
Precautionary statements and pictograms:
Other changes:
For more information, please contact: Ilaria de Rosa Carstensen
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Free web tools |
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CheMigrator® - for calculation of migration from packaging materials |
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CheMigrator® is a new tool to help you calculate substance migration when designing packaging materials such as food contact materials (FCM) or materials for medical devices. It is also a valid tool for documenting the compliance of your material with the rules and standards for FCM and medical devices. CheMigrator® comprises two databases:
Once you have selected the material and substance of interest, it is possible to calculate the related diffusion and partition coefficients or to insert experimental data. You can then calculate the degree of migration from the selected substance and material of interest. The output is a short report with a summary of the used input information together with the calculated concentration in the substrate, a comparison of the substance SML, if available, and the degree of leaching. The information can be saved. Dorte Rasmussen
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eREACHNano: web tool with information for registration of nanomaterials |
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eREACHNano is a free web tool developed to help small and medium-sized companies who may not have sufficient in-house expertise in regulation on nanomaterials. The tool is available in English and has been developed by a working group of the Nordic Council of Ministers, N-Nano, and DHI. Through a series of small video animations, the data requirements for nanoforms according to the REACH guideline documents are explained, including:
A specific revision of the REACH information requirements for nanomaterials was adopted by the European Commission in December 2018.The amendments clarify the information that companies placing substances in nanoform on the market need to provide in their registration dossiers. The new rules apply as of 1 January 2020. eREACHNano does not include the new requirements of December 2018. These will be included in a subsequent version of the web-tool to be launched later this year. The eREACHNano project is funded by the Nordic Council of Ministers, the Nordic Working Group for Chemicals, Environment, and Health, and by DHI. You can access the web-tool on http://ereachnano.dhigroup.com For more information, please contact: Dorte Rasmussen
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Medical devices |
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Consultation on draft guideline for medical devices in combination products |
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The European Medicines Agency (EMA) has released a draft guideline on the quality requirements for medical devices in drug-device combinations for public consultation. Drug-device combinations are medical devices in human medicines that include a device for the administration, dosing or use of the medicine. The guideline addresses the new obligations in the EU Medical Devices Regulation (MDR 2017/745), in particular the requirements under Article 117. Article 117 foresees that a marketing authorisation application will include a CE certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body. In the draft guideline it is specified which information about the device that needs to be submitted as part of an initial marketing authorisation application. Comments on the public consultation must be submitted by 31 August 2019. Draft guideline: Quality requirements for drug-device combinations. For more information, please contact: Lise Lyck
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Portal on EU medical devices regulations revamped |
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To help smooth the transition to the new medical devices regulations, the European Commission has launched a revamped Medical Devices section on its website. The updated website explains the main differences between the current directives and the new regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). The new regulatory requirements are presented in various sections targeted at manufacturers, importers, health institutions, authorities in non-EU countries and others. Comments on the public consultation must be submitted by 31 August 2019. Infographic with deadlines for implementation of MDR and IVDR . For further information, please contact: Brian Svend Nielsen
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Food |
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PET recycle process for FCM approved |
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The European Food Safety Authority, EFSA, has approved a recycling process of post‐consumer poly(ethylene terephthalate) (PET) flakes for use in food contact materials (FCM). The PET flakes originate from materials and articles manufactured in accordance with the EU legislation on FCM and contains no more than 5% of PET from non‐food consumer applications. The PET flakes have been evaluated and approved not to be a risk to human health when used for contact with foodstuffs for long-term storage at room temperature, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens. The approved recycling process is based on the EREMA Multi-Purpose Reactor (MPR) technology and was submitted by the Italian company Alimpet S.r.L. In the EU, recycling processes must be evaluated and authorised before the recycled plastic materials or articles are placed on the market for food contact. For more information on food contact materials, please contact: Helle Buchardt Boyd
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Avoid heating of sucralose |
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Heating of the sweetener sucralose may lead to the formation of chlorinated organic compounds with a health-damaging potential such as polychlorinated dibenzo-p-dioxins (PCDD), dibenzofurans (PCDF) and chloropropanols. This occurs especially when sucralose-containing foods such as canned vegetables or baked goods are heated. It is the German Federal Institute for Risk Assessment, BfR, which has evaluated available data on sucralose. Until further assessments are available, the BfR recommends not to heat foods containing sucralose (E 955). This applies to consumers as well as to food manufacturers. BfR opinion: Harmful compounds might be formed when foods containing the sweetener Sucralose are heated. For more information on food, please contact: Helle Buchardt Boyd
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Contact |
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