scholarly journals European chemicals regulation and its effect on innovation: an assessment of the Eu's White Paper on the strategy for a future chemicals policy

2003 ◽  
Vol 13 (2) ◽  
pp. 79-99 ◽  
Author(s):  
Ralf Nordbeck ◽  
Michael Faust
2003 ◽  
Vol 31 (3) ◽  
pp. 353-364 ◽  
Author(s):  
Robert Combes ◽  
Jennifer Dandrea ◽  
Michael Balls

In May, 2003, the European Commission published detailed proposals relating to its 2001 White Paper – Strategy for a Future Chemicals Policy. The White Paper described a new registration system called the REACH (Registration, Evaluation and Authorisation of Chemicals) system, for both new and existing chemicals. Subsequently, these detailed proposals were available for an eight-week consultation period for stakeholders to voice their views and concerns. In this paper, we describe our reactions to the Commission's more-detailed proposals. These include the creation of a European Chemicals Agency to implement the REACH system in conjunction with Competent Authorities (CAs) in Member States and the Commission itself. Unfortunately, many of our concerns and suggestions, previously voiced and shared with several other key stakeholders, remain unanswered, but are as relevant as when the White Paper was published. In particular, we are concerned about the lack of a clear and coherent strategy. There is no guidance for registrants on intelligent testing to maximise the use of non-animal approaches to safety testing, based on a combination of factors for estimating exposure levels, rather than mainly on production volumes. We are also concerned about the absence of a clear programme for the development, improvement and validation of new alternative methods, in conjunction with the Commission's own unit, the European Centre for the Validation of Alternative Methods, as well as other organisations with relevant expertise and experience, including FRAME. Finally, we explain why such measures should be introduced, together with clearer guidelines for the respective roles of the Agency, the CAs and the Commission in implementing and harmonising the REACH system at the European Union and Member State levels. A series of recommendations are made, to improve the situation and to improve the risk assessment process.


elni Review ◽  
2005 ◽  
pp. 17-21
Author(s):  
Axel Singhofen

In 2001, the Commission presented the White Paper on a Strategy for a future Chemicals Policy. Council adopted its conclusions on the White Paper in June 2001; the European Parliament adopted a resolution on it in November 2001. Both institutions welcomed the strategy and asked for it to be strengthened in various aspects. In May 2003, the Commission submitted a draft proposal for internet consultation. As a result of strong industry pressure, the proposal was watered down significantly before its formal adoption in October 2003. Council started the legislative work in January 2004. Due to the change in legislature, the European Parliament started the legislative work only at the end of 2004 and voted in November 2005. This allowed the Council under the UK Presidency to come to a political agreement at an extraordinary meeting of the Competitiveness Council in December 2005. The most fundamental deficiency of the former system was the lack of information on chemicals resulting in a lack of restrictive measures. So will REACH provide sufficient data and adequate structures to restrict and/or control chemical substances - so as to achieve a high level of protection of human health and the environment from hazardous chemicals?


2002 ◽  
Vol 30 (2_suppl) ◽  
pp. 199-202
Author(s):  
Vera Rogiers

ecopa, the European Consensus-Platform on Alternatives, is an international not-for-profit organisation, based in Belgium and complying with Belgian Law. It is the only quadripartite organisation that promotes the Three Rs at the European level. Ecopa brings together national consensus platforms on alternative methods. Consensus means that all parties concerned are represented, including animal welfare, industry, academia and government. Ecopa currently includes the National Platforms of 14 EU Member States (or future Member States; eight full members, namely, Austria, Belgium, Finland, Germany, The Netherlands, Spain, Switzerland and the UK, and six associate members, being the Czech Republic, Denmark, Italy, Norway, Poland and Sweden). Ecopa also has three working groups, concerned with: a) the 6th Framework Programme of the EC for Research, Technological Development and Demonstration Activities; b) the EC White Paper Strategy for a Future EU Chemicals Policy; and c) the formation of educational programmes on alternative methods within the EU. Ecopa is thus uniquely placed and has huge expertise to offer to the debate around political topics, including the White Paper, the 6th Framework Programme, and the 7th Amendment of the EU Cosmetics Directive. Ecopa should be considered a key stakeholder by the European Commission and Parliament, and it is essential that the views of ecopa are fully incorporated into future legislation. Recently, the ecopa working groups made a strong common statement on the Chemicals Policy White Paper and made a number of recommendations to the Commission based on scientific, practical and realistic grounds. These are to be found on the ecopa Web site ( http://ecopa.tsx.org/ or http://ecopa.vub.ac.be ).


2002 ◽  
Vol 30 (2_suppl) ◽  
pp. 211-212 ◽  
Author(s):  
Jürgen Vogelgesang

The European Commission (EC) White Paper on a Strategy for a Future Chemicals Policy calls for the collection of adequate information about chemicals, in order to ensure their appropriate risk management. The White Paper proposes a stepwise and flexible approach to all chemicals produced in amounts above 1 tonne/year/manufacturer, including testing, if information cannot be provided by other means. The required information should be collected by the end of 2012. The EC services are currently preparing the drafts for the future chemicals legislation.


Author(s):  
Lucas Bergkamp ◽  
Adam Abelkop

This chapter examines the regulation of chemicals, with emphasis on commonalities and differences in regulatory approaches. It begins with a brief overview of key concepts that underlie chemicals regulation, explaining what chemicals regulation is, the hazards and risks associated with chemicals, policy principles, informational inputs, and how chemicals are identified. The chapter then considers the general components of chemicals regulation, namely: screening and prioritization, risk assessment and decision analysis, and risk management. It also discusses regulatory fragmentation, risk management through the supply chain, and the complementary roles of regulation and liability systems. Finally, it shows how common aspects of chemical risk laws fit into the EU’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation and the US Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA).


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