Risk assessment of local dermal effects and skin sensitisation under the EU Chemicals Regulation REACH: A proposal for a qualitative, exposure scenario specific, approach

2011 ◽  
Vol 60 (3) ◽  
pp. 308-317 ◽  
Author(s):  
G. Schaafsma ◽  
A.J. Hertsenberg ◽  
J. Marquart
Keyword(s):  
Risk Assessment ◽  
Specific Approach ◽  
Exposure Scenario ◽  
Skin Sensitisation ◽  
Chemicals Regulation ◽  
Eu Chemicals Regulation ◽  
The Eu

Influence of the EU Chemicals Regulation on the US Policy Reform Debate: Is a ‘California Effect’ within REACH?

2012 ◽  
Vol 2 (1) ◽  
pp. 95-115 ◽  
Author(s):  
Dirk A. Heyen
Keyword(s):  
European Commission ◽  
Policy Reform ◽  
Business Case ◽  
Export Market ◽  
Chemicals Regulation ◽  
The Us ◽  
Reach Regulation ◽  
Eu Chemicals Regulation ◽  
The Eu ◽  
Reform Debate

AbstractIn 2006, the EU adopted the REACH Regulation – the world’s most demanding chemicals regime so far. Even before it entered into force, the European Commission declared its ambition to make REACH a global standard, and several authors see a potential for far-reaching influence via the ‘California effect’, as conceptualized by David Vogel. Economic preconditions are indeed fulfilled with the chemicals industry being highly globalized, the EU as an attractive export market and REACH applying to imports. Following Vogel, firms exporting to the EU might have an incentive to lobby for similar requirements in their country. This article examines whether American chemical producers do, indeed, push for EU-like provisions in the debate on US policy reform. While there is some influence on the US, it is shown that REACH does not (yet) trigger a ‘California effect’. The business case does not seem to be strong enough.

Hazard v. Risk in EU Chemicals Regulation

2010 ◽  
Vol 1 (3) ◽  
pp. 239-250 ◽  
Author(s):  
Kristina Nordlander ◽  
Carl-Michael Simon ◽  
Hazel Pearson
Keyword(s):  
World Trade Organization ◽  
Human Health ◽  
World Trade ◽  
Legal Framework ◽  
Chemicals Regulation ◽  
Trading Partners ◽  
Hazard Classification ◽  
Eu Chemicals Regulation ◽  
The Eu

Hazard is the potential of something to cause harm; risk is the likelihood of harm occurring. Chemicals regulation is largely focused on minimising risks associated with chemicals — and rightly so. However, in the EU the hazard classification of individual chemicals can impact significantly the regulation of products containing those chemicals, regardless of the actual risks that the products may pose to human health or the environment. This can lead to undesirable consequences, such as restrictions on the use of safe products, substitution towards less safe products, and disincentives to innovate. Such hazard-based regulation tends to be at odds with World Trade Organization rules and has raised significant concern with EU trading partners. This journal is an ideal forum for discussing how the EU can move towards a better and more coordinated legal framework for the regulation of chemicals.

Laws in Progress? Reconceptualizing Accountability Strategies in the Era of Framework Norms

2013 ◽  
Vol 2 (2) ◽  
pp. 363-385 ◽  
Author(s):  
Emilia Korkea-aho
Keyword(s):  
National Level ◽  
Eu Law ◽  
Judicial Control ◽  
Specific Focus ◽  
Chemicals Regulation ◽  
The Law ◽  
Rule Making ◽  
Peer Control ◽  
Eu Chemicals Regulation ◽  
The Eu

AbstractEU law is teeming with framework norms – ‘laws in progress’. They provide little clarity for those to whom they apply, engendering rule-making in networks to assist those charged with implementing and applying laws at the national level. Taking as its specific focus the particular process through which the concept of an ‘article’ was constructed and constituted in a set of negotiations around the EU Chemicals Regulation, REACH, this article shows that networks not only make framework norms operational but also transform them in the process. The fact that networks have an important role in laying out what the law says throws the effectiveness of traditional forms of accountability in doubt. In particular, judicial control is in need of rethinking in order to accommodate norms that change and the networks that change them. This article suggests looking at the connections between internal peer control and externally operating judicial control as a way to keep up with the progress of laws in progress.

Substitution requires all possible support

elni Review ◽  
2018 ◽  
pp. 39-46
Author(s):  
Antonia Reihlen ◽  
Heidrun Fammler ◽  
Arne Jamtrot ◽  
Martyn Futter ◽  
Jana Simanovska
Keyword(s):  
Hazardous Substances ◽  
Small Scale ◽  
Chemicals Regulation ◽  
High Concern ◽  
Joint Seminar ◽  
Phase Out ◽  
Project Life ◽  
Very High ◽  
Eu Chemicals Regulation ◽  
The Eu

In its Art. 57, the EU chemicals regulation REACH lists specific hazardous properties that are of particular concern for human health and/or the environment. Substances which have been demonstrated by Member State authorities or by the European Chemicals Agency (ECHA) to fulfil these criteria are identified as substances of very high concern (SVHCs). These substances are included on the list of candidates for authorisation under REACH, the ultimate aim of which is their eventual phase-out where technically and economically feasible. Although the awareness of chemical risks has increased in general and authorities have intensified their support to companies, the rate of substitution of hazardous substances is still criticised as too slow. In October 2018 an international seminar was jointly organised by three EU projects dealing with the reduction of risks from hazardous chemicals: “LIFE Fit for REACH” provides specific support on substitution to Baltic companies; the “NonHazCity” InterReg project identifies emission sources of hazardous substances, builds awareness and capacity in chemicals in cities and leads to emission reductions from small scale sources. The third project “LIFE AskREACH” aims at developing a smartphone app to improve communication of information on SVHCs in articles under REACH to consumers and improving related supply chain communication and awareness. At the seminar, opportunities to support substitution and overcome current barriers were discussed by experts from the EC, ECHA, Member States and different organisations, including academia, NGOs and the industry. This article describes the background of the discussions and the conclusions from the activities in the three projects, including the aforementioned joint seminar. It also contributes to the discussions on options to foster substitution in general.

scholarly journals National Food Safety Systems in the European Union: A Comparative Survey

2013 ◽  
Vol 2 (1) ◽  
Author(s):  
Andreas Hadjigeorgiou ◽  
Elpidoforos S. Soteriades ◽  
Anastasios Philalithis ◽  
Anna Psaroulaki ◽  
Yiannis Tselentis ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Food Safety ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Comparative Survey ◽  
Safety Systems ◽  
Central Level ◽  
The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

scholarly journals Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations

2021 ◽  
Vol 18 (18) ◽  
pp. 9709
Author(s):  
Eugenio Mattei ◽  
Federica Censi ◽  
Giovanni Calcagnini ◽  
Rosaria Falsaperla
Keyword(s):  
Risk Assessment ◽  
Case Studies ◽  
Medical Devices ◽  
Risk Group ◽  
Health And Safety ◽  
Implantable Defibrillator ◽  
Safety Regulation ◽  
Implantable Medical Devices ◽  
European Regulations ◽  
The Eu

Workers with cardiac active implantable medical devices (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), are considered by the occupational health and safety regulation framework as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we first describe the general methodology that shall be followed for the risk assessment of employees with a cardiac AIMD exposed to EMF, according to the EU regulation, and in particular to the EN 50527-2-1:2016 and 50527-2-2:2018 standards. Then, three case studies related to specific EMF sources are presented, to better describe how the initial analysis of the risk assessment can be performed in practice, and to understand if a further specific risk assessment analysis is required or not.

scholarly journals An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1447 ◽  
Author(s):  
Robert Carroll ◽  
Sreeram V. Ramagopalan ◽  
Javier Cid-Ruzafa ◽  
Dimitra Lambrelli ◽  
Laura McDonald
Keyword(s):  
Risk Assessment ◽  
Chart Review ◽  
Drug Utilisation ◽  
Data Capture ◽  
Primary Data ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
The European Union ◽  
Study Designs ◽  
The Eu

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that study objectives and therapeutic area influence PAS design in terms of type of data capture used.

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