Member states’ national legislation

Directive 98/8/EC, the so-called Biocidal Products Directive (BPD) was integrated into each Member State National legislation for May 14th 2000. Within the Annexes of this directive several biocidal product types are identified that are relevant either directly or indirectly to mineral processing or to the use of mineral slurries. This legislation will have an increasingly significant impact on the active substance producers, the biocidal product formulators and the end-user industries they serve. Some of the more important consequences/issues for the industry include ... 

An indicative limit value is a more common type of limit that reflects expert evaluation based on scientific data where it is possible to identify the highest level of exposure along with the corresponding reference time period for which one can have confidence that there will be no adverse effects on health. For any chemical agent for which an indicative occupational exposure limit value is established at the community level, member states shall establish a national occupational exposure limit value, taking into account the community limit value and determining its nature in accordance with national legislation and practice. 

An ED Regulation is directly applicable in each member state, without the need for transposition into national legislation. However, you will find that some supplementary national legislation is usually required so as to establish penalties and powers of enforcement at national level. 

Directives, on the other hand, are addressed to member states and require that they enact national legislation so as to achieve the objectives of the directives. Thus, a directive allows flexibility in how national legislation is enacted. In practice, national legislation will frequently refer you back to the directive, particularly when a directive contains large amounts of detailed technical requirements. 

Food additives are authorized at the EU level for all 15 member states, as well as for Norway and Iceland. The use of food additives is controlled by legislation that is harmonized across the EU. Domestic legislation in each member state is based on the various additive directives incorporated into specific national legislation. The community legislation on food additives consists of the following directives ... 

Through the adoption of Directive 91/414/EEC, a decision-making regime for determining the acceptability of a.i., which are denoted as active substances (a.s.) in the EU s legislation, was established. Authorization of plant protection products was still to be undertaken at national level by the individual Member States. 

Legislation for pesticide residues, including the setting of MRLs in food commodities, is a shared responsibility between the Commission and the Member States. To date, Community MRLs have been established for about 130 pesticide a.i. For pesticides and commodities where no Community MRL exists, the situation is not harmonized and the Member States may set MRLs at national levels to protect the health of its citizens. 

Excipients should be listed in the composition using their Ph Eur name (or one from another national pharmacopeia from an EEA member state), the International Nonproprietary Name, or an exact scientific designation, other than for materials such as preservatives or coloring agents which can be identified by an E-number. Third country pharmacopeial names may be acceptable. Coloring matter is subject to the provisions of specific legislation in the EEA. 

At the member state level, some countries, such as the Netherlands, a pioneer in the protection of soil, have their own national policies and regulations for the management of contaminated soils that were adopted before the Soil Framework Directive [132], Protection guidelines vary from country to country, and specific legislation for soil contamination only exists for some member states, including the Netherlands, Italy, Austria, France, Belgium, Germany, the UK, Denmark, Spain and Finland [128],... 

In the European Union the key instrument governing the prevention and control of pollution is the 1996 IPPC (Integrated Pollution Prevention and Control) Directive [10]. Member States were required to implement this Directive through national legislation and regulation by September 1999. 

As a result of the adoption of the above directives legislation is now in place to ensure that there is confidence not only in national laboratories but also those of the other Member States. As one of the objectives of the EU is to promote the concept of mutual recognition, this is being achieved in the laboratory area by the adoption of the AMFC directive. The effect of the AMFC Directive is that organisations must consider the following aspects within the laboratory its organisation, how well it actually carries out analyses, and the methods of analysis used in the laboratory. All these aspects are inter-related, but in simple terms may be thought of as ... 

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. 

EU Directives 2001/20/EC and 2005/28/EC set out the new rules and regulations for the approval and conduct of clinical trials in Europe. Member states had to enact the Directives into national legislation and put them into effect by May 1,2004. 

A sponsor company or a national authority may make referrals to the EMEA imder Article 10 of Directive 75/319/EEC, in order to harmonize the summary of product characteristics in all member states for products previously approved rmder national legislation. 

The secondary legislation consists mainly of regulations, directives, and recommendations. The purpose of the regulations is the unihcation of the law and thus, encroach furthest on the national legal systems as they are mandatory, i.e., apply in full in all Member States, and have direct applicability, i.e., do not have to be implemented into national law. 

EU Member States must transpose the Drinking Water Directive into their own national legislation. The Member States can include additional requirements, e.g., regulate additional substances that are relevant within their territory or set higher standards. But Member States are not allowed to set lower standards as the level of protection of human health should be the same within the whole EU. 

Marketing authorisations in the European community can be obtained at present by two main procedures - mutual recognition of a national authorisation from one Member State or a community-wide authorisation through a procedure known as the centralised procedure. In November 2005, a new procedure, known as the decentralised procedure, will be introduced under the new legislation. 

This is a new procedure introduced imder Directive 2004/27/EC. In contrast to the mutual recognition procedure, the decentrahsed procedure applies to products for which the centralised procedure is not mandatory and which are not authorised in any EU Member State. It facilitates the parallel submission to both RMS and CMSs, involvement of the CMS during the national evaluation phase, and parallel granting of national marketing authorisations after the positive finalisation of the European step of the procedure. Some of the finer details of this new procedure established under the new legislation are yet to be confirmed. 

Unlike national (such as British Pharmacopoeia, Indian Pharmacopoeia or US Pharmacopoeia) and regional (such as European Pharmacopoeia) pharmacopoeias, The International Pharmacopoeia has, a priori, no determined legal status, but WHO Member States are free to adopt it and to incorporate it into national legislation, either in part or in whole. The first edition was published in two volumes (1951 and 1955). The latest fourth edition of The International Pharmacopoeia was published in 2006 and an update is to be published in 2008. 

The Annual Reports Questionnaire (ARQ) is the mechanism through which Member States report to the United Nations on the drug control situations in their respective countries. The ARQ is integral to UNODC data collection activities. It is completed annually by member states and consists of three parts, (I) Legislative and administrative measures (II) Extent, patterns and trends of drug abuse, and (III) Illicit Supply of Drugs. 

Council Directive 76/895 (and Directives 81/36, 82/528, 88/298, 2000/24, 2000/ 57 and 2000/82, which contain amendments to that Directive) contains recommendations for MRLs for pesticide residues in or on fruit and vegetables. However, these MRLs are not mandatory and Member States may set higher MRLs in their national legislation, but not lower levels. 

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