Technical barriers to trade

The procedure under which member states are required to notify the Commission before introducing technical standards and regulations was laid down in Council Directive 98/34/EC [24], which has replaced Council Directive 88/182/EEC and Directive 94/10/EC of the EP and of the Council. This procedure aims at providing transparency and control with regard to regulations which could create unwarranted trade barriers within the single market. National provisions cannot be enforced if they should have been notified and were not [25]. 

The importance of this procedure has recently been exemplified in the area of the restriction and marketing of certain azo colorants (see Section 23.4.1.1). 

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The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

The national drag register functions as a technical barrier to trade. This conclusion is partly related to the fact that after eight years of efforts the pharmaceutical industry was considered to be the single European market s greatest failure. 

The "technical barriers to trade" formed by "reaction to fire" requirements are represented by ... 

National Tests. It is clearly possible to remove the technical barrier to trade represented by different national fire test procedures, by providing a facility for a manufacturer to conduct the relevant tests once and within his home country, with a guarantee of acceptability of the results by all Member States. This requires laboratories to equip themselves with all the necessary equipment and for an extensive interlaboratory collaboration and calibration procedure to be introduced, which would ensure mutual acceptance of test results. 

Limit tests have a long standing in pharmacopeias. For some, heavy metals for example, the sensitivity of the method was the basis for the standard. Modem limits in the USP-NF are toxicity based. There is divergence in harmonization because of toxicity-based rather than method-based standards. The modem basis avoids the exclusion of safe products from the marketplace, whereas the older approach could lead to lock-out specifications known as technical barriers to trade. 

International agreements and regional cooperation e.g. GATT, European Acquis, specify the requirements for the free movement of goods and the elimination of technical barriers to trade, mutual recognition of test results and technical harmonization, in order to meet the needs of the market. The quality concept is being broadened to include additional aspects, tools and procedures. 

The primary objective of laboratory personnel is to prodnce qnality resnlts that are mutually accepted. The harmonization of the laboratories to the CLP principles will benefit the global economy by the avoidance of the technical barriers to trade and the duplication of analytical determinations. In addition, CLP will improve the quality of life via the protection of human health and the enviromnent. 

Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment. GLP principles are explicitly presented below. 

Reduce technical barriers to trade arising from lack of traceability and equivalence. 

In September, 1986, the United States raised the EU hormone ban in the Committee on Technical Barriers to Trade of the General Agreement on Tariffs and Trade (GATT). In 1987, after a series of informal bilateral discussions, the United States invoked dispute settlement under the Tokyo Round Agreement on Technical Barriers to Trade. Formal bilateral consultations were held on two occasions without a satisfactory resolution. The United States then requested that the matter be referred to a group of technical experts. The European Union blocked the formation of the technical expert group, and the dispute went unresolved. 

WTO 1994. Agreement on Technical Barriers to Trade. World Trade Organization, Geneva. 

The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (WTO-SPS, 1994) and the Agreement on Technical Barriers to Trade (WTO-TBT, 1994) recognise as the international standards, guidelines and... 

The MRA therefore helps market acceptance of certificates and helps reduce technical barriers to trade in two specific ways. First, it provides an agreed framework within which the calibration certificates from NMIs are... 

There are several agreements of the World Trade Organization that explicitly refer to problems in trade with respect to foods derived by modern biotechnology. Within the Sanitary and Phytosanitary Agreement and within the agreement of Technical Barriers to Trade, reference is explicitly made to ISO standard and standards estab-... 

Given that global trade and international harmonization are key to the development of a sustainable life sciences industry, closer international cooperation is key to tackling technical barriers to trade in medicines. In addition to the ICH process, increasingly regulatory authorities have entered into agreements to enable them to exchange confidential information about approval and safety of medicines. 

As intended, the Directive is being adapted by MS and CA in line with scientific and technical progress, the removal of technical barriers to trade. Should any amendments become necessary, this will be through the existing Standing Committee on Medicinal Products for Human Use , which the Commission must consult if the Commission disagrees with this Committee the matters would be referred to the Council. 

Member States1 within which citizens, goods and services may cross borders without let or hindrance. Naturally, if goods are to move freely, first of all customs barriers and then the so-called non-tariff barriers or technical barriers to trade must be removed. 

In line with the spirit and wording of the WTO Sanitary and Phytosanitary, and Technical Barriers to Trade Agreements, common inter-governmental rules for equivalency assessments should be established, in order to avoid a multiplication of individual procedmes. 

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