EU Provisions

In the absence of EU provisions governing the safety of a product, it will be deemed safe if it conforms witii national laws that cover the risks the product poses. If the national safety requirements apply only to new products, the General Product Safety Regulations will apply to products supplied second-hand. A product will be deemed to comply if it conforms to an EU standard covering the relevant risks. A list of EU standards can be found on the EU s website http //europa.eu.int/comm/cons safe/ prod safe/ standards /ojc20040424.htm In the absence of specific laws or standards, assessment of product safety will be assessed by the following hierarchy of conditions ... 

Registration, evaluation, authorization of chemicals (REACH) is a regulation in Europe for the consistent continuation of the existing rules and the ideal of the EU administration regarding absolute safety for the use of chemicals within the EU. Provisions in REACH regarding essential oils are expressed as follows (58) ... 

The EU laws follow three principles related to consumer health (1) protection, (2) fraud prevention, and (3) trade barriers. The union tried to harmonize the laws of different countries, particularly in recent years when the enlargement of the European Community became dynamic. Color Directive 94/36/EC contains horizontal provisions that refer to common laws in different countries and vertical directives that apply to specific foods. The EU directives take into account the recommendations of the Scientific Committee for Food (SCF), the Codex AUmen-tarius Commission, and the Joint Food and Agriculture OrganizationAVorld Health Organization (FAOAVHO) Expert Committee on Food Additives (JECFA). 

Initial efforts by workers at the Institute for Reference Materials and Measurement (IRMM), Geel, Belgium, to produce certified reference materials for GMOs have demonstrated that the provision of suitable reference materials is not easy and that together with the development of suitable analytical methods there are many challenges to be solved ahead. The first two examples produced jointly by the IRMM in Belgium and Fluka Chemie AG in Switzerland were based on Round-Up Ready Soya and BT 176 Maize. The reference materials are needed to validate EU and Swiss regulations which permit non-GMO products to be contaminated by up to 1 % GMO material and still be accepted. 

Sustainability of energy crops is, in general, dependent on the crop species and the system boundaries considered. But the type of conversion and the use of byproducts have also considerable effect on its sustainability. Nevertheless, it can be concluded that the utilisation of energy crops considerably increase sustainability of energy provision in the EU. 

A CSR is a risk assessment, following the general provisions of Annex I of the proposed REACH Regulation, with extra guidance in Annex IB for substances that are components of preparations. These general principles correspond with the current EU practice for notified new substances and priority existing substances, as described more fully in Section 14. The ECA will develop software to help registrants prepare the CSR. It is essential to have input from downstream users to prepare the risk assessment for the CSR, which... 

Permanent bans on six phthalates in certain kinds of toys should replace the temporary ban in force for the past five years, EU Competitiveness Ministers agreed in September. Included in the proposed phthalates Directive, the provisions now face a second reading in the European Parliament. A common use of phthalates is as plasticisers to softenPVC. At the September meeting, Ministers agreed that three phthalates - DINP, DIDP and DNOP - should be banned at levels above 0.1% in toys and childcare articles intended to be sucked, while three others - DEHP, BBP and DBP - should be banned at the same level in all toys, regardless of whether they are intended for the mouth or of the age of child they are intended for. 

The enforcement in Denmark of EU Directives on food packaging materials is discussed. Enforcement activities considered include studies of total migration from food contact materials, migration from kitchen-and tableware made of melamine plastics and migration of di(2-ethylhexyl)adipate from plasticised PVC films. Activities which need to be undertaken to increase the effectiveness of enforcement activities in the field of migration are described, including development of selfinspection programmes in industry, European network of enforcement, more rapid analysis and provision of information to the consumer. 2 refs. 

An overview is presented of the CE marking requirements for manufacturers of medical devices, the role of EU Notified Bodies and third party approval and the provision of relevant data to the manufacturers of medical devices. 

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. 

Dangerous Substance Directive. Gives provisions on how to classify, package and label the individual dangerous substances that goes into the paint product (EU, 1967). 

Chemical agents Directive. Gives provisions on how to assess the risk from the handling of dangerous substances on the workplace in order to protect workers adequately (EU, 1998b). 

Safety Data Sheet Directive. Gives provisions on how and in which format to communicate information on dangerous substances and preparations (EU, 1991). 

The Seveso Directive. Sets provisions for workplaces stocking certain amounts of dangerous substances (EU, 1996). 

EU (1976) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. Official Journal L 262,27/09/1976 P. 0201 -0203... 

If REACH allows the continued production of chemicals of very high concern under a provision for adequate control, even when intrinsically less hazardous substitutes are available, it will not provide the high level of protection for human health and the environment required underthe EU Treaty. 

The authorities of the EU Member States shall inspect the laboratory and audit the studies in accordance with the provisions laid down in Annex I of the Directive 2004/9/EC... 

Directive 2001 /20/EC of the European Parhament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Eur-Lex. Official Journal of the European Communities 2001, L121 Vol. 44 34 4. http / / europa.eu.int/eur-lex/. 

The EU Clinical Trials Directive contains specific provisions regarding the conduct of clinical trials, including multicentre trials, on human subjects. It defines clinical trial as any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to... 

Prior to the introduction of EU Clinical Trials Directive, there were four ways of seeking approval for the commencement of clinical trials in the United Kingdom. These were by means of a Clinical Trial Certificate (CTC), a Clinical Trial Exemption (CTX), a Doctor s and Dentist s Exemption (DDX) or as a Clinical Trial on a Marketed Product (CTMP). Each required provision of a detailed protocol of the proposed trial. 

There are provisions for pharmacovigilance inspections with each Member State having a responsibility for this activity. However, there is currently no EU guideline and Member States have different rules and practices with regard to pharmacovigilance inspections. 

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