Concept of REACH and impact on evaluation of chemicals

2008 ◽  
Vol 27 (1) ◽  
pp. 5-21 ◽  
Author(s):  
H Foth ◽  
AW Hayes
Keyword(s):  
Safety Data ◽  
Weight Of Evidence ◽  
Main Task ◽  
The European Union ◽  
Industrial Chemicals ◽  
Chemical Safety ◽  
Substantial Impact ◽  
Production Chain ◽  
Acceptable Risks ◽  
Address Data

Industrial chemicals have been in use for many decades and new products are regularly invented and introduced to the market. Also for decades, many different chemical laws have been introduced to regulate safe handling of chemicals in different use patterns. The patchwork of current regulation in the European Union is to be replaced by the new regulation on industrial chemical control, REACH. REACH stands for registration, evaluation, and authorization of chemicals. REACH entered force on June 1, 2007. REACH aims to overcome limitations in testing requirements of former regulation on industrial chemicals to enhance competitiveness and innovation with regard to manufacture safer substances and to promote the development of alternative testing methods. A main task of REACH is to address data gaps regarding the properties and uses of industrial chemicals. Producers, importers, and downstream users will have to compile and communicate standard information for all chemicals. Information sets to be prepared include safety data sheets (SDS), chemical safety reports (CSR), and chemical safety assessments (CSA). These are designed to guarantee adequate handling in the production chain, in transport and in use and to prevent the substances from being released to and distributed within the environment. Another important aim is to identify the most harmful chemicals and to set incentives to substitute them with safer alternatives. On one hand, REACH will have substantial impact on the basic understanding of the evaluation of chemicals. However, the toxicological sciences can also substantially influence the workability of REACH that supports the transformation of data to the information required to understand and manage acceptable and non acceptable risks in the use of industrial chemicals. The REACH regulation has been laid down in the main document and 17 Annexes of more than 849 pages. Even bigger technical guidance documents will follow and will inform about the rules for application and work out of dossiers. The following article gives a comprehensive overview on the concept of REACH to give deeper insight into this document. Members of the scientific community will have to define their own position as researchers, teachers, and experts to support the efforts to protect human health and the environment. The concept of REACH as well as new approaches to adapt standard testing regimes to foster a risk oriented approach in required work load to decrease animal based tests and to strengthen weight of evidence are explained in detail in this article.

scholarly journals Canadian Regulatory Perspective on Next Generation Risk Assessments for Pest Control Products and Industrial Chemicals

2021 ◽  
Vol 3 ◽  
Author(s):  
Yadvinder Bhuller ◽  
Deborah Ramsingh ◽  
Marc Beal ◽  
Sunil Kulkarni ◽  
Matthew Gagne ◽  
...  
Keyword(s):  
Pest Control ◽  
Risk Assessments ◽  
Weight Of Evidence ◽  
Next Generation ◽  
Industrial Chemicals ◽  
Animal Testing ◽  
Chemical Safety ◽  
Testing Strategies ◽  
Integrated Testing ◽  
The Government

In 2012, the Council of Canadian Academies published the expert panel on integrated testing of pesticide’s report titled: Integrating emerging technologies into chemical safety assessment. This report was prepared for the Government of Canada in response to a request from the Minister of Health and on behalf of the Pest Management Regulatory Agency. It examined the scientific status of the use of integrated testing strategies for the regulatory health risk assessment of pesticides while noting the data-rich/poor dichotomy that exists when comparing pesticide formulations to most industrial chemicals. It also noted that the adoption of integrated approaches to testing and assessment (IATA) strategies may refine and streamline testing of chemicals, as well as improve results in the future. Moreover, the experts expected to see an increase in the use of integrated testing strategies over the next decade, resulting in improved evidence-based decision-making. Subsequent to this report, there has been great advancements in IATA strategies, which includes the incorporation of adverse outcome pathways (AOPs) and new approach methodologies (NAMs). This perspective provides the first Canadian regulatory update on how Health Canada is also advancing the incorporation of alternative, non-animal strategies, using a weight of evidence approach, for the evaluation of pest control products and industrial chemicals. It will include specific initiatives and describe how this work is leading to the creation of next generation risk assessments. It also reflects Health Canada’s commitment towards implementing the 3Rs of animal testing: reduce, refine and replace the need for animal studies, whenever possible.

Assessment of hearing dysfunction induced by industrial chemicals in presence or absence of noise: A weight of evidence approach

Toxicology ◽  
2010 ◽  
Vol 278 (3) ◽  
pp. 374
Author(s):  
Adolf Vyskocil ◽  
François Lemay ◽  
Tony Leroux ◽  
France Gagnon ◽  
Martine Gendron ◽  
...  
Keyword(s):  
Weight Of Evidence ◽  
Industrial Chemicals

scholarly journals Brexit and Animal Protection: Legal and Political Context and a Framework to Assess Impacts on Animal Welfare

Animals ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. 213 ◽  
Author(s):  
Steven McCulloch
Keyword(s):  
Animal Welfare ◽  
Agricultural Policy ◽  
Animal Health ◽  
Conservative Party ◽  
Political Support ◽  
The European Union ◽  
Substantial Impact ◽  
Animal Protection ◽  
Protection Policy ◽  
The Uk

The British people voted to leave the European Union (EU) in a 2016 referendum. The United Kingdom (UK) has been a member of the EU since the Maastricht Treaty was signed in 1993 and before that a member of the European Communities (EC) since 1973. EU animal health and welfare regulations and directives have had a major impact on UK animal protection policy. Similarly, the UK has had a substantial impact on EU animal protection. Brexit represents a substantial political upheaval for animal protection policy, with the potential to impact animal welfare in the UK, EU and internationally. Brexit’s impact on farmed animals will determine the overall impact of Brexit on animals. A major threat to animal welfare is from importing lower welfare products. A major opportunity is reform of UK agricultural policy to reward high welfare outside the Common Agricultural Policy (CAP). A soft Brexit, in which the UK remains in the single market and/or customs union, mitigates the threat of importing lower welfare products. A harder Brexit means threats to animal welfare are more likely to materialise. Whether threats and opportunities do materialise will depend on political considerations including decisions of key political actors. The Conservative Government delivering Brexit has a problematic relationship with animal protection. Furthermore, Brexit represents a shift to the political right, which is not associated with progressive animal protection. There is significant political support in the Conservative Party for a hard Brexit. Further research is required to investigate whether the various threats and opportunities are likely to materialise.

scholarly journals Upholding the EU's Commitment to ‘Animal Testing as a Last Resort' Under REACH Requires a Paradigm Shift in How We Assess Chemical Safety to Close the Gap Between Regulatory Testing and Modern Safety Science

2021 ◽  
pp. 026119292110408
Author(s):  
Julia Fentem ◽  
Ian Malcomber ◽  
Gavin Maxwell ◽  
Carl Westmoreland
Keyword(s):  
European Commission ◽  
Paradigm Shift ◽  
Modern Science ◽  
Transformational Change ◽  
Weight Of Evidence ◽  
Animal Testing ◽  
Chemical Safety ◽  
Policy Makers ◽  
Safety Science ◽  
Animal Safety

Animal use for testing chemicals under REACH continues to increase, despite advances in non-animal safety science during the past 15 years. The application of modern science and technology, and the use of ‘next generation’ weight-of-evidence assessment approaches, are embedded in EU guidance for establishing the safety of cosmetics and foods – and of the ingredients used in these products. However, this is still not the case for the regulation of chemicals. Under the new Chemicals Strategy for Sustainability, thought leaders in human health and environmental protection are calling on the European Commission to quickly embrace the benefits of modern and innovative non-animal safety science, in place of outdated animal testing, if the EU is to be a leader in safe and sustainable innovation under the European Green Deal transformational change ambitions. The European Commission also needs to enable companies to meet their legal obligation to only conduct animal testing as a last resort, by providing a more flexible, science-based and consistent regulatory framework for assuring chemical safety, which supports the integration of data from different sources. We are at a tipping point for closing the gap between regulatory chemicals testing and modern safety science. It is time to join forces, across policy makers, scientists, regulators and lawyers, to lead the paradigm shift needed to deliver what EU citizens want – namely, chemicals and products that are safe and sustainable, without resorting to animal testing.

scholarly journals A Review of Coffee By-Products Including Leaf, Flower, Cherry, Husk, Silver Skin, and Spent Grounds as Novel Foods within the European Union

Foods ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. 665 ◽  
Author(s):  
Tizian Klingel ◽  
Jonathan I. Kremer ◽  
Vera Gottstein ◽  
Tabata Rajcic de Rezende ◽  
Steffen Schwarz ◽  
...  
Keyword(s):  
European Union ◽  
Animal Feed ◽  
Safety Data ◽  
Coffee Bean ◽  
Green Coffee ◽  
The European Union ◽  
Spent Coffee Grounds ◽  
Novel Food ◽  
Coffee Grounds ◽  
By Products

The coffee plant Coffea spp. offers much more than the well-known drink made from the roasted coffee bean. During its cultivation and production, a wide variety of by-products are accrued, most of which are currently unused, thermally recycled, or used as animal feed. The aim of this review is to provide an overview of novel coffee products in the food sector and their current legal classification in the European Union (EU). For this purpose, we have reviewed the literature on the composition and safety of coffee flowers, leaves, pulp, husk, parchment, green coffee, silver skin, and spent coffee grounds. Some of these products have a history of consumption in Europe (green coffee), while others have already been used as traditional food in non-EU-member countries (coffee leaves, notification currently pending), or an application for authorization as novel food has already been submitted (husks, flour from spent coffee grounds). For the other products, toxicity and/or safety data appear to be lacking, necessitating further studies to fulfill the requirements of novel food applications.

scholarly journals Great Civilizations Population Increase/Decrease Factor

2017 ◽  
Vol 22 (1) ◽  
pp. 5-12
Author(s):  
Andi Mihail Băncilă
Keyword(s):  
Asylum Seekers ◽  
Population Increase ◽  
Main Task ◽  
The European Union ◽  
European Continent ◽  
Special Event ◽  
Majority Population ◽  
Different Cultures ◽  
Permanent Residents

Abstract Demographic changes that currently affect the planet are not fully new, they have continued throughout history, managing to influence geographical areas and making changes to individuals’ lifestyle. The phenomenon of international migration has become a topical issue in 2015 with the increasing number of asylum seekers on the territory of the European Union. This special event raised new questions about the socio-economic evolution of the European continent, with problems being signaled both from the perspective of newcomers and permanent residents of this space. The main task that the political authorities of the member states of the community block have over the next years is to identify a solution through which to achieve appropriate and long-term integration of newcomers, many of them belonging to different cultures of the majority population.

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