European regulatory control

The legislative framework of the European Union is separated into a multi-tier system through which proposed regulations and changes in policy are discussed and debated. The European Parliament is made up of 

The Fifth Environmental Action Plan was issued in 1993 and runs to 2000 and is entitled Towards Sustainability . The Treaty of European Union (TEU) adds several elements of the environmental provisions of articles 130r to 130t of the Treaty of Rome. European unity sets the objective, amongst other things, to promote sustainable and non-inflationary growth respecting the environment as one of the activities of the EC. 

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In order to establish consensus on the scope of the endocrine disrupter issue, to facilitate the identification of active chemicals and, ultimately, to underpin any future regulatory control, it is essential to agree a precise definition of an endocrine disrupter (ED). Such a definition was proposed at a major European Workshop on EDs. ... 

The European Commission (EC) has sponsored four reports that evaluate a set of 553 substances selected by experts and stakeholders for assessment for endocrine disruption. Each report addresses a subset of the total set based on priorities such as whether the chemicals are persistent, bioaccumulating or High Production Volume chemicals and/or whether or not there is already regulatory control of the chemical. 

Enforcement methods provided by the manufacturer are not generally tested in the laboratories of the European regulatory authorities. Very often, proposed methods are evaluated by assessing the logic of proposed procedures and only for the completeness of validation data. For this theoretical review process, as much information as possible should be available. Recovery data from many validation experiments with different kinds of matrices and the resulting chromatograms of control and fortified samples provide the confidence needed by the referee. In the following sections, the most important aspects of this evaluation will be considered. 

This chapter begins by summarising the recent review articles on this topic. Other topics such as sources and physico-chemical characteristics of ambient and emerging nanoparticles (i.e. ENPs) are then covered briefly for the completeness of the article. This is then followed by the assessment of nanoparticles in numerous European cities, estimation of respiratory deposition doses and a brief discussion on current and future prospects of their regulatory control. In what follows, the terms airborne nanoparticle and ENP refer to total particles, currently mainly produced by vehicles, and nanomaterials-derived products, respectively. 

Before completion of an EU risk assessment on TCE, Sweden decided that epidemiological evidence on the hazardous properties of the chemical was sufficient to warrant strict regulatory control in the workplace (through the application of Article 138 of the EC Treaty). Sweden therefore began to implement a company use-specific authorisation system. Sweden s action was later challenged by the European Commission as causing unnecessary barriers to trade, but a European Court of Justice ruling upheld the Swedish system. 

Copper Chlorophyll. Current efforts to improve the green color of processed foods include the use of copper complexes of chlorophyll derivatives. Copper complexes of pheophytin and pheophorbide are available commercially under the names copper chlorophyll and copper chlorophyllin, respectively. Their use in canned foods, soups, candy, and dairy products is permitted in most European countries under regulatory control of the European Economic Community (47). The Food and Agriculture Organization (FAO) of the United Nations (48) has certified their safe use in foods provided that no more than 200 ppm of free ionizable copper is present. Use of copper-containing chlorophyll derivatives in foods is not allowed in the United States under the Color Additive Amendment to the Food, Drug, and Cosmetic Act of 1938. 

COMMISSION OF THE EUROPEAN COMMUNITIES, An Approach to the Exemption from Regulatory Control of Radioactive Waste no Linked to the Nuclear Fuel Cycle in the European Community, Rq>ort EUR 14520 EU (1992). 

The European Commission, as part of its policy to encourage industry to adopt more sustainable practices, created the EMAS system in 1993. EMAS was also seen as a move towards stated the EU goal of encouraging industry to adopt more self-regulatory practices and a move away from command and control type central legislation. 

A Regulatory Apologia - a Review of Placebo-Controlled Studies in Regulatory Submissions of New-Generation Antidepressants , European Neuropsychopharmacology (2008)... 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

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