Directives from European Union

From European Union (Council Directive 92/58/EEC of 24 June 1992)... 

As referred to above, most of the modules involve the intervention of a third party, the so-called notified bodies. These bodies are designated by Member States as being competent to carry out the certification tasks for which they are notified. As a precondition for their notification they must fulfil the minimum criteria which are set out in the relevant directives. These conditions vary from independence, impartiality and professional integrity, to technical competence, possession of or access to necessary facilities and to liability insurance. Once notified, the Commission publishes a list of all notified bodies in the Official Journal, It is worth noting that there is free competition between notified bodies and that manufacturers can make their own choice from all notified bodies notified within the European Union. 

The directive will initially come into force on 29 November 1999. From that date until 28 May 2002 manufacturers have a choice between applying the pressure equipment directive or continuing with the application of the existing national legislation. From 29 May 2002 the pressure equipment directive will be obligatory throughout the European Union. 

The Council of the European Union. Council Directive 98/24/EC of 7, April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at ujork. Offi cial Journal No. LI 31, May 1998. 

Attempts to harmonize European pharmaceutical laws were accelerated in the 1980s. From 1985 onwards, a substantial number of European pharmaceutical directives have been adopted. This entire legislation has been published in the form of a nine-volume series entitled The Rules Governing Medicinal Products in the European Union (Table 4.11). These volumes form the basis of EU-wide regulation of virtually every aspect of pharmaceutical activity. 

The European Union has unanimously voted to reverse a proposal from the European Parliament to phase out two brominated flame retardants, penta- and octa-BDE. This formed part of a forthcoming directive on a third member of the PBDE family. The proposed directive now returns to the Parliament for a second reading in early 2002, by which time risk assessments should be completed. Parliament also agreed that deca-BDE should be banned by 2006, though only if the risk assessment validated this. EUROPEAN COMMISSION... 

An examination is made of the provisions of European Union directive 1999/13/CE covering the reduction and control of emissions of volatile organic compounds arising from the use of organic solvents. 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

The role of biocomponents in traffic fuel is increasing. The European Union Directive [1] on the promotion of the use of biofuels for transport purposes states that by the end 2005 traffic fuels should have contained 2% of components produced from renewables. The figure rises to 5.75% by the end of 2010 and up to 20% by the end of 2020. This directive defines biofuel as a liquid or gaseous fuel for transport produced from biomass, biodiesel as a methyl ester produced from vegetable or animal oil, of diesel quality, to be used as biofuel and synthetic biofuel as synthetic hydrocarbons or mixtures of synthetic hydrocarbons, which have been produced from biomass. The European Commission also encourages member states to lower tax rates on pure and/or blended biofuels, to the offset cost premium over petroleum-based fuels [1, 2]. 

World-wide demand for glycerol is projected to be 0.2 Mt in 2007 and is forecasted to grow by 2.2% per year, driven mainly by personal care and food products [10]. If the target of the European Union directive is achieved, European biodiesel demand could increase to 10 Mt per year by 2010, resulting in 1 Mt of glycerol [2]. The price of glycerol has already fallen by 50% over the past ten years [10, 11]. Thus, the application of glycerol, obtained from the biodiesel process,... 

The initial HMF content in all honey samples was lower than the allowed maximum limit of 40 mg/kg as recommended by Turkish Alimentarus Codex [17], for honey in general. These results contradict the observation made by some authors that the types of honey produced in subtropical climates have high HMF exceeding 40 mg/kg [18]. However, the European Union council directive also allows for a maximum of 80 mg/kg for honey from tropical climates. The HMF level in honey is said to depend on the type of sugar present in honey and the fructose glucose ratio [19]. The HMF formation results from the acid catalyzed dehydration of hexose... 

Consequently, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation and regulatory guidance has been issued in the European Union (EU). Recently, Directive 2001/83/EC [12], as amended by Directive 2004/27/EC [13], requires an evaluation of the potential environmental risks to be performed for every application for each active ingredi-ent/excipients from every medicinal product to be authorized. However, the... 

Different smdies have focused on the levels of BPA in infants and young children. Volkel et al. [216] found BPA in the urine of 42% (LOQ 0.45 ng/mL) of 91 samples from 47 infants, aged between 1 and 5 months. The highest concentration observed (17.9 ng/mL) was 18-fold below the TDI of 50 pg/kg body weight per day. Infants who were fed using baby bottles showed approximately twofold higher median levels of total BPA. Important to note is that the sampling of the infants was performed before the ban of polycarbonate baby bottles in the European Union was declared (EU Directive 2011/8/EU). 

The European Union passed the Extractive industries waste directive in 2006. The fuii titie of the directive is Directive 2006/21/EC of the European Pariiament and of the Councii on the management of waste from extractive industries and amending Directive 2004/35/EC ... 

The European Union (EU) and its Member States promote responsible research in order to help society draw the maximum benefit from scientific inquiry and in order to protect the rights of citizens, researchers, and other members of society (EU 2007). All EU-funded research activities must comply with an ethical code according to Article 3 of the Sixth Framework Programme (FP6, 2002-2006) that states All the research activities carried out under FP6 must be carried out in compliance with fundamental ethical principles. No further guidance specifically directed toward the use of human data in the risk assessment of chemical substances is provided. 

The European Union s advisory Committee, the CPMP, was set up in 1975 under Directive 75/319. The first meeting was held on 26 November 1976 and Mr Leon Robert from Luxembourg was appointed its first Chairman. The Professional Head of the then UK Medicines Division, Dr EL Harris, who was also the UK Representative to CPMP, was elected a Deputy Chairman. Dr JP Griffin, initially his alternate but later the UK representative during 1977-84, was appointed Chairman of the CPMP Working Party on Safety. Dr NMG Dukes from the Dutch regulatory... 

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