The Chemical Sciences and Equality, Diversity, and Inclusion.

There has been mounting concern over the absence of gender equality in the sciences in recent years. This has been accompanied by a broadening of the perspective, in order to address issues of equality, diversity and inclusion, relating to a wide range of circumstances in which individuals suffer discrimination. While some progress has been made in some countries, nationally or at the level of institutions, much more needs to be done. The chemical sciences can play a leading role in addressing biases, through 1) becoming a model of good systemic practice in policies, processes, and actions; 2) developing practical skills through training in cultural competence; and 3) promoting a stronger evidence base to uncover both the extent of problems and the degree to which approaches to improve equality, diversity, and inclusion are working.

The patenting of novel biotech products.

Patent laws covering NCEs are well established in most developed countries. For such entities to be patentable, they must be novel, inventive and have some practical use. Furthermore, the patent applications must describe how to make the entities, and provide data to support the patent claims. The same criteria are being applied by Patent Offices to the patenting of the new generation of biotech products: genes, proteins, microorganisms, transgenic plants and transgenic animals. This feature review focuses on the patenting of these novel products.

Chemical safety in a vulnerable world.

The title of this article is the motto of the fourth meeting of the Intergovernmental Forum on Chemical Safety (Forum IV), which is to be held in Bangkok in November 2003. The IFCS has been in existence for 10 years. During this period politicians, scientists, and the general public have become increasingly aware of the risks associated with chemicals. International conventions providing for prohibitions and restrictions of dangerous chemicals, and for better control of trade have been set up. These conventions will soon be binding under international law. In developing countries many people who handle or use hazardous chemicals are illiterate or poorly educated; they may not fully understand what they are handling. The industrialized countries therefore have a special duty to incorporate chemical safety in development cooperation measures. Through their presence at this year's forum, prominent chemists such as Carl Djerassi will seek to underline the fact that a long term preventive approach to healthcare and the environment is only possible through international cooperation. This overview describes current developments in the field of chemical safety policy and presents a selection of the legislation currently in force for chemicals in the European Union. It also provides an insight into the interwoven structure of international cooperation that takes place at both the political and the technical level.

A critical assessment of the European Commission's proposals for the risk assessment and registration of chemical substances in the European Union.

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.

The new EU chemicals policy--Discussions on details relevant for animal welfare.

The European Commission is planning to put forward drafts for a new chemicals legislation by June 2002. In fulfillment of an Environmental Council Conclusion, Working Groups have been set up for consultation during the ongoing preparatory stage. There, members of the General Directorates Environment and Enterprise discuss relevant topics with representatives from authorities, industry, environmental and animal protection organisations. There is agreement that animal tests shall be reduced to a minimum. However it is still unclear how this goal can best be achieved. In this context, the designing of testing strategies will play a major role. It is explained, why fixed test catalogues should be replaced by flexible tiered testing strategies and how concrete waiving strategies can contribute to avoiding animal tests. Another important aspect is the EU-wide implementation of a clause on the avoidance of duplicate testing, which is already enforced in Germany and Austria. In these Member States, first parties have to provide data from previously performed animal tests to second parties. Finally, it is discussed that the application of new non-animal tests can be promoted, if the revised EU chemicals policy once again contains the legal framework for an EU-specific acceptance of new test methods.

[White Paper of the European Commission--strategy for a new chemicals policy]. / Das Weibetabuch für eine neue Chemikalienpolitik der EU: Bewertung der Chancen von in vitro Methoden aus der Sicht von ZEBET.

The current chemicals regulation in EU member states provides sufficient data on new chemicals but almost non on the about 100.000 existing chemicals. To improve the situation the EU Commission is proposing in a recent White Paper on a strategy for a new chemicals policy to regulate new and existing chemicals in an identical manner. The Commission suggests to use in vitro methods to provide information rapidly on hazardous health and environmental properties of chemicals. The fundamental change in the testing strategy, which is relying on in vitro methods rather than testing in animals is most welcome not only from the scientific and economic point of view but also from the perspective of the protection of animals and the environment. A calculation of the costs and time for testing all existing chemicals in animal experiments shows that this task is unrealistic from a financial point of view and also when taking into account the time required for testing. Taking into account the proposals provided by several working groups of the EU validation centre ECVAM during the past year, a concept is described that will allow the testing of all existing chemicals applying only non-animal tests. Since the new testing strategy will be cheaper and faster it will be more acceptable from both the financial and the ethical point of view. Finally, establishing the proposed new in vitro tests in the safety testing strategy will require considerable funding of validation studies by the EU Commission.

ECVAM, ECETOC and the EU chemicals policy.

ECVAM's initiatives in validation have received significant support from the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), especially through the provision of reference chemical data banks, which contain peer-reviewed, high-quality in vivo data on commercially available chemical substances. Chemicals have been selected from these ECETOC data banks for validation studies on alternative methods for skin corrosion and irritation and for eye irritation and, in addition, an ECETOC task force peer-reviewed the selection and classification, on the basis of in vivo data, of chemicals used in the validation of three alternative methods for developmental toxicity. More recently, ECVAM and ECETOC have been pursuing parallel initiatives on the proposed new EU chemicals policy, with the common goals of ensuring that industry and European Commission resources are used to investigate only those chemicals that pose a significant risk to human health and the environment, and that the Policy requires that any testing which is required follows the Three Rs principles of reduction, refinement and replacement.

The EC White Paper on a Strategy for a Future Chemicals Policy.

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.