European Union Community authorisation

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

Raw materials or goods which are exported to the USA are subjected to the same restrictions as those which are manufactured within the USA. There is also a duty to ensure that each delivery is authorised by the US customs authorities. Anybody who does not conform to these so-called TSCA (Toxic Substances Control Act) conditions must reckon on a high fine. This article examines in detail all the legal, administrative and financial steps that must be followed before making the first exports, including adhesives. EUROPEAN COMMUNITY EUROPEAN UNION GERMANY USA WESTERN EUROPE... 

The European Commission has adopted a directive which limits the emission of volatile organic compounds due to the use of organic solvents in certain industrial activities. The directive sets emission limits for these compounds and lays down operating conditions for industrial installations. In addition, under the directive, new installations must be registered or be authorised to carry out their activities. Further requirements of the directive are listed. EUROPEAN COMMUNITY EUROPEAN UNION WESTERN EUROPE-GENERAL... 

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. 

In the European Union, a medicinal product may only be placed on the market when the competent authority of a Member State for its own territory (national authorisation) has issued a marketing authorisation or when the European Commission (EC) has granted an authorisation for the entire Community (Commimity authorisation). 

In the European Union there have been several petitions to approve stevia and its products. In 2000, the EU Commission refused marketing authorisation for Stevia rebaudiana Bertoni plants and dried leaves as a novel food or novel food ingredient (Official Journal of the European Communities, 2000). In October 2003, the SCF rejected a request to re-examine the restrictions on the uses of extracts of stevia. Its comment, after throroughly examining the evidence, was that the committee has serious doubts about the safety of stevioside and does not consider it acceptable for use in food (European Parliament, 2003). 

National marketing authorisations were intended to be phased out from 1 January 1998. It was foreseen that beyond that date, all marketing authorisations within the European Union would have been issued under the rules governing medicinal products in the European Community through the Centralised Procedure, or the so-called Mutual Recognition or Decentralised Procedure (see below). However, national approvals for marketing have continued well beyond 1 January 1998. 

Directive 2002/7/EC. 2002. Amending Council Directive 96/53/EC laying down for certain road vehicles circulating within the Community the maximum authorised dimensions in national and international traffic and the maximum authorised weights in international traffic. Official Journal of the European Communities, Vol. 67, pp. 47-49. Brussels The Council of the European Union. 

Health claims are a very convenient tool when it comes to marketing functional foods due to consumers sensitivity to health-related communications. The use of nutrition and health claims on foods in the European Union (EU) was harmonised in 2006 by Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (EC, 2006). Only the use of authorised nutrition and health claims is allowed. All health claims require specific authorisation by the European Commission (EC) through the comitology procedure, following the scientific assessment and verification of a claim by the European Food Safety Authority (EFSA) (Pravst, 2012a). 

Official Journal ofthe European Union 30.4.2004, L 136/1 Regulation (EC) No. 726/2004 of the European parliament and of the council of 31 March 2004 laying down Community procedures for the authorisation... 

On June 1, 2007, the European Community put into force a new regulation called Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Although it specifically applies to manufacturers within the European Union and manufacturers that import into the EU, it is becoming the de facto worldwide standard for regulation of chemical products. All firms that handle one metric tonne or more per year of any chemical product or produce any chemical product that is new to commerce are covered. For many existing chemical products, new data will need to be measured to determine hazards more accurately. Details of the regulation are available at http //echa.europa.eu. 

EU the European Union of 28 countries (2013) with 20 official languages, formerly known as the European Community (EC) and originally the European Economic Community. The Biocidal Products Directive and Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) determine pesticide regulatory status throughout the EU (http //europa.eu.int/). 

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