Community legislation

In addition these directives had to be decided unanimously by the European Council which made their adoption cumbersome and slow. These directives are now referred to as old approach directives. A radical change was needed so that the Community legislation could respond to the needs of both, the completion of the internal market for the products concerned, and the need to offer to industry a flexible legislative environment which would encourage technical progress. 

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 imit for the evaluation of medicinal products for veterinary use has also been involved in the PERF initiative as well as other activities related to implementation of community legislation and the quality of medicinal products. 

The Directive covers 23 different product types specified in Annex V of the Directive. These include disinfectants used in different areas, chemicals used for preservation of products and materials, nonagricultural pesticides, and antifouhng products used on hulls of vessels. The Directive will not apply to certain product types already covered by other community legislation, such as plant protection products (PPPs) (Section 2.4.1.7.2), medicines, and cosmetics. 

The Act has been frequently amended as appropriate to ensure that it is in line with the European community legislation. Given the remarkable degree of similarity between the requirements under the Medicines Act 1968 and the legislations prevailing at the time in the United States and the European Economic Community (EEC), the existence of four major legislations, together with their amendments and... 

Since the United Kingdom joined the European Community all EU pharmaceutical regulation and legislation is transposed into the UK national pharmaceutical regulation and legislation. The primary aim of the Community legislation is laid down in the preamble to the Council Directive of 26 January 1965 (65/65/EEC), which states that ... 

Only European Community legislation printed in the paper edition of the Official Journal of the European Union is deemed authentic. 

The objective of the EU community legislation is to protect human health and to prevent different national legislation that may hinder free trade within the EU. 

European Community legislation on materials and articles intended to come into contact with food... 

For the time being the Commission will probably seek to add to the present Community legislation other directives which should have as their immediate objectives ... 

European Commission (1998) Report on the operation of community legislation in the chemicals sector. COM (1998) 587/3. 

R. Zubek, Implementation of Community Legislation in Poland and Institutional Configurations at the Centre of Government, Department of Government Working Paper, London School of Economics and Political Science, London, UK, 2002. 

The Authority will provide scientific advice which will serve as the scientific basis for the preparation of Community legislation in the field falling imder its mandate. In this respect there is a clear separation of the responsibility of the risk assessment function and that of risk management which will remain the responsibility of the Community Institutions, i.e. the European Commission and Parliament and the Council. The Authority will become the point of reference with respect to risk assessment. Its precise role will evolve over time but its role with respect to the authorisation process had become clearer following the publication of a number of recent Commission proposals. In such a proposal on smoke flavourings used or intended for use in or on foods [4], the Commission proposed that dossiers should be submitted directly to the Authority, and within a predetermined period of time the opinion of the Authority should be returned to the Commission which will remain responsible for the development of proposals on food law. The Commission following consultation of Member States in the newly created Standing Committee for the Food Chain and Animal Health will ultimately take decisions. 

The European Food Safety Authority has been established to provide independent scientific advice and support for the Community legislation and policies that may have a direct or indirect effect on food and feed safety. It will provide independent information on all matters within its remit and communicate with the public and other interested... 

National provisions on specific materials still exist in areas where Community legislation is not adopted. The rule of mutual recognition applies to this national legislation. Any product lawfully produced and marketed in one Member State must, in principle, be admitted to the market of any other Member State. The only reason a Member State can reject a product is on the basis of protection of human health. Even under mutual recognition, national legislation may foresee that the use of a substance lawfully manufactured and/or marketed in another Member State is subject to prior authorisation provided certain requirements are fulfilled such as a simplified procedure for having the substance included on a national list. In non-harmonised areas... 

The Community legislation comprises general mles applicable to all materials and articles laid down in the Framework Regulation and specific rules only applying to certain materials or certain substances. The two general principles on which legislation on food contact materials is based are the principles of inermess and safety of the material. A general overview is presented in Fig. 3.1. 

All authorisations granted are general authorisations. This means everybody may use a substance authorised. There exists also the possibility to authorise the use of substances, materials or processes only for the individual petitioner. Authorised substances are listed in specific Community legislation. The Framework Regulation contains a list of materials for which specific legislation may be adopted. This list comprises 17 different materials. Only a few are yet covered by specific Community legislation (see sections 3.4 and 3.5). 

Harmonisation of national legislation on the substances used in food contact plastics was started with monomers as these are reactive substances and thus of primary importance as regards any potential health risk. Monomers and other starting substances are fully harmonised at Community level. This means that only the monomers listed in the specific Community legislation can be used in food contact plastics. An exemption exists for plastic coatings, adhesives and epoxy resins. Monomers which are used only in their manufacture are not listed in the Community lists. 

In a second step, the harmonisation of additives used in plastic food contact materials was started. However, this step is not yet finished Therefore, additives listed both in the Community legislation and in national legislation can be used in food contact plastics (for national lists see section 3.7). It is foreseen that harmonisation on additives will be finalised by 2007. Until 31 December 2006 all parties interested in additives authorised at national level have to supply EFSA with a valid application for evaluation of this additive. Only additives for which a valid application has been supplied may continue to be used according to national audorisation until evaluation is finalised by EFSA and a decision on authorisation is taken by the European Commission. The Community list on additives contains those additives that are used solely in plastics and those used both in plastics and coatings. However, it does not contain additives used only in plastic coatings, adhesives and epoxy resins. 

The OFFC Regulation establishes a hierarchy of methods used for sampling and analysis in applying official controls. First priority is given to methods laid down in Community legislation. If these do not exist, methods according to internationally established rules such as those of CEN or those in national legislation should be applied. In the absence of these methods other methods fit for the purpose or developed in accordance with scientific protocols shall be used. In the area of food contact materials analytical methods are laid... 

Community legislation was introduced to harmonise national legislation and to remove barriers to trade. Member States legislation is based on different principles and this can still be observed in those areas which are not yet covered by Community legislation. Four main legal systems can be distinguished. 

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