Legal requirements for protection of the natural environment are continually being strengthened because of increased human damage to environmental resources. The applicable regulations of the Polish ...Penal Code towards protection of the environment were considerably amended in 2011 also to ensure implementation of European Parliament and European Council directives 2008 / 99 / EC, issued on the 19th November 2008. In addition, these changes also involve cross-border infringements, so that perpetrators cannot avoid retribution for actions committed under different provisions in individual Member States.
An appropriate method for evaluating the air quality of a certain area is to contrast the actual air pollution levels to the critical ones, prescribed in the legislative standards. The application of ...numerical simulation models for assessing the real air quality status is allowed by the legislation of the European Community (EC). This approach is preferable, especially when the area of interest is relatively big and/or the network of measurement stations is sparse, and the available observational data are scarce, respectively. Such method is very efficient for similar assessment studies due to continuous spatio-temporal coverage of the obtained results. In the study the values of the concentration of the harmful substances sulphur dioxide, (SO
2
), nitrogen dioxide (NO
2
), particulate matter - coarse (PM
10
) and fine (PM
2.5
) fraction, ozone (O
3
), carbon monoxide (CO) and ammonia (NH
3
) in the surface layer obtained from modelling simulations with resolution 10 km on hourly bases are taken to calculate the necessary statistical quantities which are used for comparison with the corresponding critical levels, prescribed in the EC directives. For part of them (PM
2.5
, CO and NH
3
) this is done for first time with such resolution. The computational grid covers Bulgaria entirely and some surrounding territories and the calculations are made for every year in the period 1991–2000. The averaged over the whole time slice results can be treated as representative for the air quality situation of the last decade of the former century.
Use of hormones for fattening purposes is forbidden in the animal production in Europe (European Commission. 1996. Council Directive EC/96/22 (replacement of 88/146/EC). Off J Eur Commun. L125:3–9; ...European Commission. 1996. Council Directive EC/96/23. Off J Eur Commun. L125:10–32). Moreover, Regulation (EC) 178/2002 (European Commission. 2002. Regulation EC No 178/2002. Off J Eur Commun. L31:1–24) and Regulation (EC) 882/2004 (European Commission. 2004. Regulation EC No 882/2004. Off J Eur Commun. L165:1–135) oblige the member states to identify emerging risks and use validated and accredited methods for control analysis. Only combinations of bioassay activity screening with chemical identification are suited to uphold all laws. No such combination is described for the detection of (gluco)corticoids. In the present study, the GR-CALUX bioassay was validated as a qualitative screening method for the determination of glucocorticoid activity in feed. This validation was performed according to EC Decision 2002/657/EC (European Commission. 2002. Commission Decision 2002/657/EC from Directive 96/23. Off J Eur Commun. L221:8–36). Twenty-two representative blank feed samples were selected and spiked with 50 ng g⁻¹ of dexamethasone, 100 ng g⁻¹ of betamethasone or 500 ng g⁻¹ of triamcinolone. All blank and spiked feed samples fulfilled the CCα and CCβ criteria; the method was specific and robust and glucocorticoids in feed were stable for at least 88 days.
Zusammenfassung
Überwiegend wird das Recht der Europäischen Gemeinschaft (EG) in Richtlinien vorgegeben. Das gilt auch für den Bereich der Arzneimittel, Medizinprodukte, Blut- und ...Gewebezubereitungen. Die Festlegungen der EG-Richtlinien werden grundsätzlich erst dann wirksam, wenn sie in innerstaatliches Recht der Mitgliedsstaaten der Europäischen Union (EU) umgesetzt sind. Die Umsetzung ist zwingend und macht das EG-Recht in den EU-Mitgliedsstaaten verbindlich. Die Richtlinie 2004/23/EG zur Festlegung von Qualitäts- und Sicherheitsstandards für Gewebezubereitungen (EG-Geweberichtlinie) ist mit dem Gewebegesetz vom 20. Juli 2007 abschließend in deutsches Recht umgesetzt worden. Sie legt Mindeststandards fest, über die der nationale Gesetzgeber aufgrund der Besonderheiten dieser EG-Richtlinie im Sinne strengerer Vorschriften hinausgehen kann. In der Wahl der Rechtsinstrumente zur verbindlichen Umsetzung des EG-Rechts ist der nationale Gesetzgeber frei. In Deutschland sind die Anforderungen der EG-Geweberichtlinie in dem vorgegebenen Rechtsrahmen, vor allem im Arzneimittelgesetz, im Transplantationsgesetz und im Transfusionsgesetz umgesetzt worden.
Because of a failure to harmonize the regime of takeover defenses, the European Directive on Takeover Bids (DTB) has created broad dissatisfaction. In fact, two key features of the DTB, the board ...neutrality rule and the break-through rule (BTR), are not mandatory, but can be opted out by Member States. Since both rules were considered chief devices for increasing takeover activity, as they aim to neutralize the most significant anti-takeover defenses, the fact that their adoption will rely upon local choices by national legislatures puts into serious question whether the ultimate outcome of the DTB will be that of promoting a vibrant and efficient pan-European market for corporate control. Optionality is not alone in thwarting harmonization in the field of takeover defenses, as the European legislature has also introduced a reciprocity feature, according to which Member States can decide whether to relax the prohibitions and restrictions arising out of the board neutrality rule and/or the BTR in the event a bid is made by a company which is not subject to the same prohibitions and restrictions. Although the DTB failed the goal of promoting a strong takeover market by limiting the availability of defensive tactics, both the optionality and the reciprocity features will represent an intriguing test of how Member States will address the underlying policy choices and, where they chose to opt out of the board neutrality rule and/or the BTR, of how companies will react to the possibility of deciding to opt into the pro-takeover EC default regime. The paper argues that optionality: (i) may very well be a sound approach with regard to the BTR, as its beneficial impact is still highly debated, and (ii) represents an acceptable compromise for the gradual implementation of the board neutrality rule. Quite plausibly, at this stage, an abrupt introduction of a mandatory board neutrality rule would have generated, at least in some Member States, a backlash in both national politics and corporate practice. The paper also stresses that reciprocity does not represent a sound policy to govern the regime of takeover defenses.
Moderne Diagnostik und Entwicklung innovativer chemisch-definierter Arzneimittel haben wesentlich zur Reduktion von MorbiditÄt und LebensverlÄngerung gefÜhrt. Parallel hierzu wurden Über Jahrhunderte ...bewÄhrte, auf Empirie von 'Trial and Error' basierende Naturheilmittel durch EG-Rechtsanforderungen mit Nachweis von QualitÄt, Wirksamkeit, Unbedenklichkeit, Paradigmenwechsel zur evidenzbasierten Medizin, PharmakoÖkonomie mit Vorgaben von Leitlinien und politische Restriktion verdrÄngt und die Ärztliche Erfahrung und Therapiefreiheit eingeschrÄnkt. Es stellt sich die berechtigte Frage nach der Relevanz und Übertragbarkeit von experimentellen Daten auf den Menschen und die ÜberschÄtzung ephemerer klinischer Ergebnisse aus randomisierten klinischen Studien auf den Einzelfall. Patienten, Ärzte und fachkompetente Natur-Wissenschaftler fordern, der Naturheilkunde neben der Schulmedizin innerhalb der Grundversorgung einen gebÜhrenden Platz einzurÄumen. Mit Inkrafttreten der Richtlinie 2004/24 EG und Umsetzung in nationales Recht besteht neben dem Weg der Zulassung als 'well-established medicinal use' basierend auf pharmakologisch-toxikologischen Studien oder bibliographischen Unterlagen, fÜr Phytopharmaka mit langer Tradition die MÖglichkeit eines vereinfachten Registrierungsverfahrens als 'traditional use'. Hierdurch kann langjÄhriger Erfahrung in der medizinischen Anwendung Rechnung getragen und der Stellenwert der Phytopharmaka in Europa gefestigt werden.
In the larger scope to which the geocide concept is applicable, protective (and punitive) legislation is highly overdue for waters. There is urgency as pollution of all waters, desertification and ...eutrophication must be controlled.
The strategy for the improvement of occupational safety and health is presented. The role of the state and the workers in shaping working conditions has changed over the years, and this process is ...traced through ILO and EC documents. There must be a coherent up-to-date national policy in this field. Safety and the protection of the workers' health is perceived by the Community legislation not only in the terms of the worker's individual interest, but also from a social viewpoint, consisted in striving for general improvement of the work environment. The Community regulations aspire to satisfy the public interest, and directives set the maximum level of protection but also serve as minimum standards not infringing the more favourable national regulations. They define requirements that should already be met at the planning and designing stages.
Today, two international certification schemes exist for hazardous area. One scheme is endorsed in Europe under the ATEX Directives the other scheme is the IECEx system which provides a more ...international but voluntary equipment certification scheme accompanied with the conformity mark license scheme and other certification schemes for service facilities and persons. This paper targets at audience from plant operators, engineering contractors, installers and equipment manufacturers involved with hazardous area equipment. The paper outlines the similarities and differences between the two schemes in order to help answering questions like: 1. Which certification requirements are applicable to equipment on plants? 2. What is the most convenient way to certify assemblies? 3. What about equipment with certificates of component? 4. What are the benefits of the voluntary IECEx certification scheme? 5. Which scheme is the best choice in which situation?
In Germany a comprehensive system of legislation and institutions for prevention of occupational diseases and accidents at work has been built up over more than 100 years. The paper presents ...regulations and new initiatives in the field of occupational health and safety, undertaken in the country, known as the Act on Company Doctors and compares it with the EU recommendations.
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