PANEL 5: Substances of concern (SVHCs) in products – whose job is it to control these in a free trade world? - Ravi Agarval, Director, Toxics Link, India
PANEL 5: Substances of concern (SVHCs) in products – whose job is it to control these in a free trade world? - Karin Kilian, Policy Officer, EU-Commission
PANEL 5: Substances of concern (SVHCs) in products – whose job is it to control these in a free trade world? - Ravi Agarval, Director, Toxics Link, India
PANEL 5: Substances of concern (SVHCs) in products – whose job is it to control these in a free trade world? - Karin Kilian, Policy Officer, EU-Commission
How to tackle chemicals of high concern in products – The construction Sector as a case study. Stylianos Kephalopoulos, Leader of Competence Group Exposure, European Commission – Joint Research Centre
PANEL 4: Speeding up chemical assessments: from novel information to new management approaches, what works? - Erika Kunz, Head of Global Registration and Evaluation of Chemicals, Clariant, Germany
Call for articles, special issue on: "The Future of Ecolabels"Fabio Iraldo
The German Environment Agency (UBA), the Oeko-Institute, adelphi consult GmbH and the Institute for Research on Energy and Environmental Economics and Policy (IEFE) of Bocconi University are promoting and launching the present call for contributions. The call aims to identify and describe the key challenges facing ecolabels, such as defining criteria to deal with critical raw materials, chain-of-custody and traceability of raw material value chains, integration of social criteria and human rights aspects in ecolabels, addressing issues of product durability and obsolescence and implementing a harmonized performance and impact measurement system for ecolabels.
Jukka Malm: European Regulatory Framework for Chemicals - Protecting Citizens...THL
Jukka Malm, Deputy Executive Director, European Chemicals Agency (ECHA), at Europe That Protects - Safeguarding Our Planet, Safeguarding Our Health EU side event, 3-4 Dec 2019, THL, Helsinki
How to tackle chemicals of high concern in products – The construction Sector as a case study. Stylianos Kephalopoulos, Leader of Competence Group Exposure, European Commission – Joint Research Centre
PANEL 4: Speeding up chemical assessments: from novel information to new management approaches, what works? - Erika Kunz, Head of Global Registration and Evaluation of Chemicals, Clariant, Germany
Call for articles, special issue on: "The Future of Ecolabels"Fabio Iraldo
The German Environment Agency (UBA), the Oeko-Institute, adelphi consult GmbH and the Institute for Research on Energy and Environmental Economics and Policy (IEFE) of Bocconi University are promoting and launching the present call for contributions. The call aims to identify and describe the key challenges facing ecolabels, such as defining criteria to deal with critical raw materials, chain-of-custody and traceability of raw material value chains, integration of social criteria and human rights aspects in ecolabels, addressing issues of product durability and obsolescence and implementing a harmonized performance and impact measurement system for ecolabels.
Jukka Malm: European Regulatory Framework for Chemicals - Protecting Citizens...THL
Jukka Malm, Deputy Executive Director, European Chemicals Agency (ECHA), at Europe That Protects - Safeguarding Our Planet, Safeguarding Our Health EU side event, 3-4 Dec 2019, THL, Helsinki
OECD Green Talks LIVE: Global eChemPortal to information on chemical substancesOECD Environment
To meet public health and environmental objectives for the safe use of chemicals under proper conditions, increasing understanding of chemical hazards and risks is key. By increasing access to data and information, governments and industry can work to reduce – or even eliminate – adverse health effects from exposures to chemicals.
The OECD eChemPortal provides direct access to critical scientific information on chemical substances of regulatory relevance with over 800,000 substance records from 37 databases. The portal allows countries and companies to share work, ensure resource efficiencies, and, subsequently, reduce animal testing.
Gerlinde Knetch (Germany), Jake Sanderson (Canada) and Violaine Verougstraete from Eurometaux shared their experience in improving chemical safety and how the eChemPortal supported this process.
Are you prepared for the upcoming Substances of Concern In Products legislation requirements? We've answered all SCIP FAQ in order for you to plan ahead and plan for your compliance submissions.
Stakeholder presentation at the ESPP stakeholder meeting on STRUBIAS and EU Fertilisers Regulation (05/09/2018) organised by the European Sustainable Phosphorus Platform (ESPP, www.phosphorusplatform.eu)
More workshop outcomes at:
https://phosphorusplatform.eu/activities/conference/meeting-archive/1728-espp-stakeholder-meeting-on-strubias-and-eu-fe
EU Fertiliser Regulation dossier by ESPP can be found at: http://phosphorusplatform.eu/regulatory
Updated February 2017: This slide deck gives background to, and an update on, the Falsified Medicines Directive and Delegated Regulation. More more information about the FMD, please visit: http://www.abpi.org.uk/our-work/falsified-medicines-directive/Pages/default.aspx
On December 18, 2006, the European Parliament passed the final REACH Directive. Work on this legislation began in 2003. REACH will begin to be phased in on June 1, 2007.
REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States. Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations.
This regulatory briefing provides a summary of some of the key elements and concepts of the REACH Directive. For more information on EH&S and product responsibility services, go to:
http://calthacompany.com/compliance-programs-ems-auditing
New Product Registration - Key Considerations when Registering New ProductsCovance
The regulation related to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was adopted by the EU in 2007 in response to worldwide initiatives to address the impact of chemicals on human health and the environment. REACH requires all manufacturers and importers of chemicals into European markets to assess and manage the risks associated with their substances and products, and register them with the European Chemicals Agency (ECHA). To manage this project, ECHA split existing substances into three categories, based on the amount of the substance that is used annually, with different registration deadlines for different tonnages of use.
“SURVEY ADDRESSED TO END-USERS” presented at the "H2020 projects for evidence-based agricultural related policies" roundtable at the European Parliament on the 25th April 2018.
Do not hesitate to contact EMPHASIS project through:
Facebook https://www.facebook.com/emphasisproject/
Twitter https://twitter.com/EmphasisProject
Email emphasisproject@gmail.com
Website http://www.emphasisproject.eu
Slideshare https://www.slideshare.net/EMPHASISPROJECT/
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
EU and US Procedures for API Registration - Commonalities and DifferencesMilliporeSigma
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
This presentation, created by Syed Faiz ul Hassan, explores the profound influence of media on public perception and behavior. It delves into the evolution of media from oral traditions to modern digital and social media platforms. Key topics include the role of media in information propagation, socialization, crisis awareness, globalization, and education. The presentation also examines media influence through agenda setting, propaganda, and manipulative techniques used by advertisers and marketers. Furthermore, it highlights the impact of surveillance enabled by media technologies on personal behavior and preferences. Through this comprehensive overview, the presentation aims to shed light on how media shapes collective consciousness and public opinion.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
0x01 - Newton's Third Law: Static vs. Dynamic Abusers
June 9 2017 Panel 5 Remi Lefevre
1. Panel 5 – Substances of
concern in products – whose
job is to control these in a free
trade world?
09 June 2017
Helsinki Chemicals Forum 2017
Rémi LEFÈVRE
2. 2
Manufacturer
Formulator
End user /
Article producer
Import of
articles
Article
assemblers
Article retailers End users of articles
Comprehensive set of
obligations for
information generation
and communication
within supply chains
- Less information
- Less substances: Candidate
List substances only!!!
What does REACH foresee?
3. 3
What we observe…
EU-made articles
In REACH Registration dossiers:
• description of use in articles
is lacking or too generic
• exposure assessment
methods/tools lacking
• no waste stage information
Imported articles
• very limited information /
no updating
• 368 notifications, for 39
Candidate List substances
• limited enforcement
Poor compliance!
4. 4
The consequences (1/2)
For retailers (EU importers):
• responsibility left to their suppliers on
the safety of the products they sell (risk
of crisis)
• limited ownership of their products
For users of articles/consumers:
• no information on what is present in
articles no “right to choose”
• limited or no information on how to use
(and dispose of) products safely
5. 5
The consequences (2/2)
For regulators:
• difficult to identify potential sources of
concern
• and to regulate quickly and efficiently
6. 6
Why?
Are supply chains:
too complex?
with too different actors?
too volatile?
Are materials’
compositions
changing too
quick?
Other reasons?
?
7. 7
What shall be done?
Awareness
raising
Regulatory measures
& enforcement
By whom?
Guidance /
Support to development
of standard
communication formats
or IT tools
9. Thank you!
Subscribe to our news at:
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@EU_ECHA
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remi.lefevre(at)echa.europa.eu