European Union legislative requirements

European Union Legislation Requires Companies to Provide Detailed Information on Chemicals... 

The 1999 Gothenburg Protocol led to the establishment of new European Union legislation, Directive 2001/81/EC on National Emissions Ceilings for Certain Pollutants. The Directive set upper limits for each member state for the total emissions of SO2, NO, , VOCs, and ammonia, four pollutants responsible for acidification, eutrophication, and ground-level ozone pollution. Member states are allowed to determine which measures they will take to comply with the directive, but are required to report annually on their national emission inventories and projects for 2010. ... 

The European Commission consists of 25 members. The commissioners are citizens of the 25 member states but are required to act independently and in a nonpartisan way. Only the Commission can initiate proposals for new legislation, following consultations with governments, industry, labor, and special interest groups and, as required, technical experts. The principle of subsidiarily, enshrined in the Treaty of the European Union, hmits legislative proposals to areas where European Union legislation offers benefits over the legislation of individual member states. 

Recently, similar legislation has been introduced in the European Union under regulations EC/1901/2006 and EC1902/2006. This requires that marketing authorisation applications for new drugs submitted after the 28 July 2008 must be accompanied by either the results of specific studies demonstrating safety and... 

Since food colorants are used as food additives, they must also comply with legislative requirements. Food legislation in the European Union (EU) and the United States (US) differs with regard to additives and labeling. Therefore, this section provides an overview of legislation in the EU (Section 7.1.6.1) and the US (Section 7.1.6.2) and discusses colorants permitted for use in food products according to the different requirements. 

For example, in order to meet the demanding requirements of legislation such as the European Union (EU) Baby Food Directive (Directive 95/5/EC and subsequent revisions), analysts must improve on the scope and sensitivity of multiresidue methods of analysis. This Baby Food Directive, which became effective on 1 July 2002, limits residues of all pesticides to a maximum level of 0.01 mgkg There will also be a banned list of pesticides, annexed to the Directive, which will not permit the use of certain pesticides on crops intended for use in baby food production. As a consequence, food manufacturers often require residue results for raw or primary ingredients within 24 8 h of sample receipt at the laboratory. 

With respect to development pharmaceutics data, the requirements stated in Directive 75/318/EEC (as amended) are included in the Annex to that document at Part 2 A 4 (page 20 of the Rules Governing Medicinal Products in the European Union, Volume 1, Pharmaceutical Legislation Medicinal Products for Human Use). With respect to the general requirement for pharmaceutical products this states 4.1 An explanation should be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product. This explanation shall be supported by scientific data on development pharmaceutics. The overage, with justification thereof, should be stated. This, then, is the legal requirement. Needless to say, there is a... 

European Union and Italian legislation relating to hazardous chemicals is reviewed, with particular reference to classification and labelling requirements. 

Many rubber products, when exported to the member states of the European Union, must comply with the requirements of the relevant legislation approach. The EU Directives of New Approach and Directives of Sectoral Approach are legislative provisions that must especially be followed. Directives of New Approach confine the requirements to the protection of health, property and environment and the safety requirements. The Directives of New Approach lay down the uniform procedure of approval of conformity. Harmonised European standards, giving detailed specifications of the product, follow these Directives. Detailed requirements are given in the Directives of Sectoral Approach and they have to be interpreted individually. The essential concepts are explained and a review of the most important documents is presented. 

In the European Union the key instrument governing the prevention and control of pollution is the 1996 IPPC (Integrated Pollution Prevention and Control) Directive [10]. Member States were required to implement this Directive through national legislation and regulation by September 1999. 

Consideration of the above requirements confirms that in future all methods must be fully validated if at all possible, i.e. have been subjected to a collaborative trial conforming to an internationally recognised protocol. In addition this, as described above, is now a legislative requirement in the food sector of the European Union. The concept of the valid analytical method in the food sector, and its requirements, is described below. 

Antioxidants should be labelled on the retail package with the specific chemical name or with the EC number. The legislation of member states of the EU is influenced by the decision taken within the EC. Some food standards are fully based on EC Directives and some are still based on national considerations. There may be differences between European states, for instance, the utilisation of ascorbic acid as antioxidant for egg products is permitted in France but prohibited in Germany. These differences concern usually the utilisation of antioxidants in various food commodities. The specification of antioxidants mentioned in EC Directives are respected by all member states. But it is still generally required that individual countries of the European Union as well as the central organisation should be approached. The requirements appearing in the EC Directives on additives must be applied by the member states. This means in the first place that for those categories of additives for which a Community positive list exists, member states may not authorise any additives which do not appear on the positive list. 

Recently the protection of the environment has become increasingly important for industry with the requirement that the potential impact on the environment is considered for all aspects of industrial processes. Such considerations are supported by environmental legislation that controls all types of emissions as well as the treatment of wastes. Such legislation is based on global standards that have largely resulted from developments within the European Union, Japan, and the United States in collaboration with international conventions. Of these, the Basel Convention (1989) and the Earth Summit in Rio de Janeiro (1992) were significant in the control and prevention of wastes. In the case of liquid wastes that are most appropriate for treatment by liquid liquid extraction, limits for discharge into the aqueous environment have been established by the three countries already mentioned. These limits depend on the particular country and sometimes on the industry. (See section 14.6.)... 

Consequently, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation and regulatory guidance has been issued in the European Union (EU). Recently, Directive 2001/83/EC [12], as amended by Directive 2004/27/EC [13], requires an evaluation of the potential environmental risks to be performed for every application for each active ingredi-ent/excipients from every medicinal product to be authorized. However, the... 

---