EU LEVELS

A different system applies to the creation oflegislationat EU level. The EU is based on a series of treaties between member states, which are comparable to constitutional law at national level. Three institutions are involved in the creation of EU law (i) The European Gommission (ii) The Council of the European Union and (iii) The European Parliament. 

Food additives are authorized at the EU level for all 15 member states, as well as for Norway and Iceland. The use of food additives is controlled by legislation that is harmonized across the EU. Domestic legislation in each member state is based on the various additive directives incorporated into specific national legislation. The community legislation on food additives consists of the following directives ... 

The Ecodesign Directive is the regulation that sets standards for products (products, goods) at EU level. Thus, for the RISKCYCLE issue, principle regulations could be established for the pre-consumer phase, so that only those chemical additives may be used that do not cause problems in a sustainable closed substance cycle. 

Table 3. Likely maximum EU Level 1 testing programme ...

Applications for particular uses of very high concern substances will be assessed at EU level, on the basis of the risk assessment submitted by the applicant, that covers all stages of the life-cycle for that use. The risk assessment is to focus on a more detailed estimation of exposure for the use, and generally no new safety... 

As required by Directive 89/107/EEC, criteria of purity have been drawn up for all the listed food additives (with a couple of exceptions). Purity criteria for all the permitted sweeteners have been prescribed in Directive 95/31/EC,6 as amended, and criteria for all the permitted colours are contained in Directive 95/ 45/EC,7 as amended. Directives that prescribe purity criteria for all the additives authorised under Directive 95/2/EC have been drawn up in stages. Directive 96/ 77/EC8 containing purity criteria for antioxidants and preservatives is amended by Directives 98/86/EC which lays down purity criteria for emulsifiers, stabilisers and thickeners and 2000/63/EC which contains purity criteria for most additives numbered E 500 and above, and for certain other additives not covered in the earlier directives. Purity criteria for most of the few remaining permitted miscellaneous additives are contained in Directive 2001/30/EC however, purity criteria for E 1201 polyvinylpyrrolidone and E 1202 polyvinylpolypyrrolidone are still being considered by the Scientific Committee on Food. Some methods of analysis for verifying prescribed purity criteria have been developed at EU level these are contained in Directive 81/712/EEC.9... 

European Commission (2007) Green paper towards a Europe free of tobacco smoke pohcy options at the EU level. Available at http //ec.europa.eu/health/ph.overview/health forum/ docs/ev 20071128jd03.en.pdf... 

By way of introduction, the most important project results are outlined here. Initially, the project focuses on the main issues, i.e. the abihty to be iimovative and the direction of innovation, and also on the current reforms in chemicals legislation taking place at EU level. After that, selected results are highhghted and explained. 

REACH is an acronym comprising the most important elements of the new chemicals legislation at EU level Registration, Evaluation and Authorisation of CHemicals, cf http //europa.eu.int/comm/enterpiise/chemicals/chempol/whitepaper/reach.htm Cf Grupp et al 2002, Dominguez-Lacasa et al 2003... 

Important conseqnences for the formnlation of the new chemicals legislation on EU level (REACH) and evalnation of its possible effects on innovation are created from these correlations ... 

This is probably a fundamental driver for the present REACH process at EU level. 

The duties of ECVAM are to coordinate the validation of alternative test methods at the EU level, to act as a focal point for the exchange of information on the development of alternative test methods, to set up, maintain, and manage a database on alternative procedures, and to promote dialogue between legislators, industries, biomedical scientists, consumer organizations, and animal welfare groups, with a view to the development, validation, and international recognition of alternative test methods. 

Regarding all activities for the regulation of pharmaceuticals at the EU level. Article 71 of Regulation EEC/2309/93 that established the EMEA and the CPMP required that Within 6 years of the entry into force of this Regulation, the Commission shall publish a general report on the experience of the procedures laid down in this Regulation, in Chapter 111 of Directive 75/319/EEC and in Chapter IV of Directive 81/851/EEC. The tender for review was awarded to a consortium of Cameron McKenna and Arthur Anderson. The full report from Cameron McKenna, dated October 2000 and entitled Evaluation of the Operation of Community Procedures for the Authorisation of... 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

The crosses indicate that two electrons are fed into the non-degenerate atu level (one with spin a, the other with spin / ) and that four electrons are fed into the doubly degenerate eu level the whole making up the ground state 77-electron configuration (aa )a(eu). ... 

Suggestions for Specific Action in Critical Areas and on EU Level... 

A number of tools have been developed to test the scope of the relevant market. However, it has not been necessary to use these tools in undertaking this study since, in all cases, an appropriate market had already been defined in competition law investigations at both the UK and the EU level. The products chosen within these sectors, and associated geographical markets as established in competition cases, are set out in Table 1. Since all these decisions were arrived at recently, there is little reason to believe that the nature of the markets will have changed substantially since then. 

NFPs maintain and develop the national network, facilitate and co-ordinate contacts, requests and deliveries at the national and EU level. In addition, they act as advisers to their EEA Management Board members and develop contacts with other relevant networks such as Eurostat. In order to promote key EEA publications, many NFPs organise launch events and issue press releases. 

In addition, there is an IFOAM group, which advises the EU Commission on matters pertaining to organic agriculture. This group is made up of representatives from each of the IFOAM members in the EU, and provides a non-govemmental route for advising at an EU level. 

The final column in Table 9.4 displays the geometric similarity measure for the current lists of OELs. This similarity measure can only range between 0 and 1. The closer the national exposure limits are to EU exposure limits, the closer is the geometric similarity to one. As can be seen in Table 9.4 the Estonian exposure limits are the ones most similar to the EU OELs. Least similar to the EU OELs are the Swedish exposure limits. The geometric similarity of the national OELs tends to increase over time. This means that the national exposure limits are approaching the EU level. 

On the EU level, biocidal products are mainly regulated by the Biocidal Products Directive (98/8/EG), which came into force in 2000. A biocidal substance or product is defined as Active substances and preparations containing one or more... 

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