Europe directives defined

Decoquinate is another quinolone derivative also incorporated in the feed. It is administered at a level of 20-40 ppm in the feed continuously for prevention of coccidiosis in broiler chickens, at 100 ppm for 28 days for prevention of coccidiosis in ewes and lambs, and at 500 ppm for at least 28 days for prevention of coccidiosis in cattle. Many feedlot farmers also use a 28 day feeding program for all incoming cattle to guard against costly disease that can destroy a feedlot. It is an approved feed additive in Europe, as defined by Directive 70/524/EEC (47). 

In Europe chemically defined substances with flavouring properties, which are obtained by chemical synthesis, are defined in the European Union Flavouring Directive 88/388/EEC [6], article 1 No. 2(b) (ii) and (iii) in two categories (see 7.1 and 7.4.2) ... 

The EU Directive [3] introduced the concept of an individual taking responsibility for releasing a batch of product to market. This position, uifique to Europe, is defined by the Qualified Person. This individual has to take decisions independent fi om the Board. The role is further elaborated on in the Guide to GMP (see also Sect. 25.3.4). This role is only defined for products with a Marketing Authorisation and Investigational Medical Products. However the function is equally applicable to preparations made by the pharmacist. Pharmacies should nominate a person, independent of the preparation function, to be responsible for the release of the preparation. 

Requirements for labelling of containers for supply may differ from those for conveyance. Key features of a supply label are to identify the substance (the chemical name in most cases) and any hazards and safety precuations. In Europe the classification, packaging and labelling of dangerous substances is covered by Directive 67/548/EEC as amended. This requires labels to identify appropriate risk and safety phrases (Tables 12.2 and 12.3) depending upon product properties. A substance is considered dangerous if in Part lA of an approved list or if it exhibits hazardous properties as defined in Schedule 1 for supply, or Schedule 2 for conveyance as shown in Tables 12.4 and 12.5. Substances not tested should be labelled Caution — substance not yet fully tested . Criteria for risk phrases are provided, e.g. as in Table 12.6 for toxic compounds. 

The Penumbra stroke system (Penumbra Inc., San Leandro, CA) includes two different revascularization options (1) thrombus debulking and aspiration may be achieved by a reperfusion catheter that aspirates the clot while a separator device fragments it, and (2) direct thrombus extraction may be performed by a ring retriever while a balloon guide catheter is used to temporarily arrest flow. This system has been tested in a pilot trial in Europe. Twenty patients (mean NIHSS 21) with a total of 21 vessel occlusions (7 ICA, 5 MCA, and 9 Basilar) were treated up to 8 hours after symptom onset. Recanalization prior to lA lysis was achieved in all cases (48% TIMI 2 52% TIMI 3). Seven patients were also treated with lA UK or rt-PA. Good outcome at 30 days (defined as mRS < 2 or NIHSS 4-point improvement) was demonstrated in 42%. The mortality rate was 45%, but there were no device-related deaths. There was one asymptomatic SAH and three symptomatic ICHs. A prospective, single-arm, multicenter trial is being conducted in the United States and Europe currently. 

The new Biocidal Products Directive is examined, which closes the gap in European legislation for products such as disinfectants and anti-foulants where there has not, until now, been a Europe-wide standard. The basic goals of the directive are to simplify and harmonise Europe s regulatory framework for biocides, and to remove trade barriers within the EU, and to improve the protection of both human health and the environment. The new directive must be enforced as national legislation in all member countries by 14 May 2000. Details are given of products defined within the directive, and ways in which the directive will be put into practice in the UK are discussed. The implications of the legislation on the industry in terms of time and money spent on testing for each active substance involved are examined. 

In the legislation of different national governments, some limits were defined especially for wastewater and air. The activities in Europe are covered by the Council Directive 96/61/EC concerning Integrated Pollution Prevention and Control (IPPC) [9]. This means that all... 

Another interesting example that further illustrates this issue is the differences in regulations concerning D C yellow 10 and Quinoline yellow between the United States and Europe. Although the Color Index (Cl) numbers are the same, the dyes differ in composition as defined in the regulations. Quinoline yellow s purity criteria is defined in European Directive 94/45/ EC as El04, which requires that the material contain not <80% of the disulfonated component of the dye and not >15 /o of the monosulfonated component. D C yellow 10 is listed in the U.S. 21CFR (74.1710) which requires that the dye contain not <75 /o of the monosulfonated component and not >15 /o of the disulfonated component of the dye. ... 

The purity criteria specifications for colorants approved for use in Europe are laid down in European Directive 95/45/EC. Each colorant defined by an EEC number has a monograph listing the required... 

Ten years later, a pair of Directives extended the provisions of 65/65. Directive 75/318 defined testing and protocol standards, while Directive 75/319 introduced the Committee for Proprietary Medicinal Products (CPMP) and what is now known as the mutual recognition procedure (MRP) for MA (see below). Nine years later, the structure of the CPMP was adjusted by Regulation 726/2004, and now forms the CHMP (see below). These three fundamental Directives represent the basis of pharmaceutical regulation that is common to the whole of Europe the creation of the EMEA in 1995 (by Regulation 2309/93, two years earlier) provided the machinery that implements these Directives. 

Monitoring surface water, ground water, seawater, effluents and drinking water for toxic compounds is traditionally carried out by discrete (spot) sampling that is followed by chemical analysis in the laboratory. This provides qualitative and quantitative information on specific analytes, in Europe often focused on the priority substances defined by the EC Water Framework Directive, WFD (European Commission, 2000). Although... 

Landfill Directive (99/31/EC) Introduced new technical and operational requirements for landfills across Europe and targets for the reduction in landfill of biodegradable wastes.The Decision (2003/ 33/EC), which comes into force in July 2004, is crucial for the implementation of the 1999 Landfill Directive. It outlines criteria for the waste that can be accepted at each of the defined types of site and for underground storage, sets out strict EU-wide leaching limit values and defines testing methods. The criteria are to be applied by Member States by July 2005. 

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