Legislative harmonization

Other efforts at harmonizing food laws occur between partners of the North American Free Trade Agreement (NAFTA) involving the United States, Canada, and Mexico, and between Australia and New Zealand. A suggested approach to legislative harmonization is depicted in Figure 12-4. The existence of a model food act developed by CA should be an incentive in bringing about harmonization within and between countries. 

The Directives were drawn up under the new approach to legislative harmonization whereby the main body of the Directive lays down only broad objectives to be met and qualifies these with annexes specifying particular areas or parts to be given consideration which in turn rely on harmonized (EN) standards to detail the techniques to be used as evidence of conformity. SMSR has followed this pattern. 

Lack of global harmonization on regulation/ environmental policy Legislation - cost of end-of-pipe treatment... 

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 ... 

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. 

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. 

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. 

Importantly, this was a volimtary effort there was no legislative or treaty mandate to harmonize. No organization can compel harmonization. Further complicating the proeess are the differences among times to appearance of a first monograph, revision of publication schedules, public notice and eomment opportunities, and updating pro-... 

Currently, legislation covering the discharge of metals into the environment is monitored, controlled, and devised by individual countries or regions. However, there is a move toward harmonizing of such legislation led by the United States, the European Union, and Japan. 

A harmonized pan-European notification system, i.e., covering the entire EU, was introduced for new substances as part of the 6th Amendment to the 67-Directive (EEC 1967), which was adopted in September 1979 (Directive 79/831/EEC - EEC 1979) and came into force in all Member States on 18 September 1981. Over 6800 notifications in total, representing more than 4300 substances, have been submitted since 1981. Inherent of legislation are principles for notification, including criteria for exemption. Exemption categories include consumer products pertaining to pharmaceuticals, cosmetics, and foodstuffs. The Directive is not applicable to pesticides, radioactive materials, wastes, and substances used in scientific research (ECB 2006). 

Current work on the new EU legislation for chemicals, REACH, as well as the implementahon of a Globally Harmonized System of Classihcation and Labeling of Chemicals (GHS) (Sechon 2.5) within the EU will lead to a major revision of the EU classihcation and labeling system. 

While the establishment and implementation of national traceability systems is left to the countries and their legislation, the mutual recognition of these national systems calls for an international mechanism, at least if worldwide mutual recognition is aimed at. The MRA of the Meter Convention for national measurement standards and calibration and measurement certificates issued by NMIs [2] can be expected to at least provide for one important aspect of the task, namely the establishment of international equivalence at the national standards level. Together with the success of the work currently carried out by the International Laboratory Accreditation Cooperation (ILAC) for the harmonization of national laboratory accreditation schemes, the MRA will be the key to comparability and hence to ac-... 

As a consequence of EU Directive 78/142/EEC, which introduced a limitation of vinyl chloride monomer both as residual amount in final articles (QM lmg/kg) intended to come into contact with foodstuffs and in migration to food (SML not detectable LOD 0.01 mg/kg), the corresponding necessary analytical methods were developed between several European expert laboratories and laid down as agreed methods in EU Directives 80/766/EEC and 81/432/EEC, respectively. This piece of the EU harmonization process was too time- and work-consuming to continue in this way. The vinyl chloride Directives therefore remain a unique feature in EU food packaging legislation since this was found to be impractical for generalization. 

A full analysis of current legislation in the European Community should also take into account the national rules and recommendations in force in certain countries on articles or materials not yet harmonized by Community directives, which this report does not do. The Council of Europe, however, prepares resolutions to which the Member States of the Community often refer in the absence of Community directives or national legislation. 

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