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Archive: News and Views 2008 July

Content: Metric Labeling only OR Supplementary Indications?

Dear valued Client,

MDSS received a number of requests in regards to the metric only requirement. MDSS investigated the issue and we would like to provide the following update:

The consolidated version of the current European Union Council Directive 80/181/EEC (Metric Directive) can be found here:

It would allow the use of dual-unit measurements only until the end of 2009 (e.g. the indication of length in meter [m] and inch [in or “]). Beginning January 1, 2010, the use of non-metric units for products sold in the European Union (EU) would therefore be prohibited. The directive would require manufacturers to label all products marketed in the European Union exclusively in metric units. From that day on, dual-unit measurements would no longer be permitted on product labels, brochures and advertisements in the EU.

Now the good news: The European Union is in the process of updating the directive. The proposal from the commission took the concerns provided to them in the public consultation process into consideration (e.g. comments of the US:

A careful review and an impact assessment were conducted which resulted in a commission proposal which can be found here:

Instead of extending to allow the use of supplementary indications for another ten years as being done 3 times (89, 99, 2009) in the past, an indefinitely allowance is indicated.

According to our current information the directive is in its final approval stages and needs to be adopted in due time by the member states. You may monitor the progress here:

This solution seems to be good for trade on both sides of the Atlantic since it would incur unnecessary cost for such sudden change.

The Conversion to the Metric in the US

The International System of Units (abbreviated SI from the French Système International d'Unités) is the modern form of the metric system. The metric system is a system of measurement based on the meter and the gram. The base units are a choice of seven well-defined units – meter, kilogram, second, ampere, Kelvin, mole and candela. Since the 1960s the SI has been the internationally recognized standard metric system and was set into force by the 11th General Conference on Weights and Measures (CGPM, Conférence Générale des Poids et Mesures).

The metric system was designed to replace different systems by a unified, natural and universal system of measurement for both everyday and scientific purposes.

The USA (besides Liberia and Burma) has developed its own measurement standard which is based on natural measures such as league, grain and fathom for historical reasons. As trade and commerce constantly grow and as the metric system is the most widely used and accepted one in international communication there is an increasing necessity to have more consistent measures. It is believed that the competitiveness of American products and services in world markets would be enhanced by completing the change to the international standard measurement system based on metric units.

A three-year study of systems of measurement performed in the U.S. already in 1968 revealed that measurement in the United States was already based on metric units in many areas and that it was becoming more so every day. The majority of study participants believed that conversion to the metric system was in the best interest of the nation, particularly in view of the importance of foreign trade and the increasing influence of technology in American life. As a result of the above a process of voluntary conversion was initiated, and the metrication program was established.

However, in some public areas it is certainly difficult to switch to a new system. Therefore the conversion to Metric is not yet finalized. Medicine is generally metric, but where interaction with patients is required, usage of a different system is indicated. In many cases for which metric units are otherwise used, the practice often varies. Therefore, the use of dual measurement units is still indicated to ensure patient safety. This may lead to some additional technical solutions. For example, diabetes patients measure their blood sugar levels in milligrams per deciliter, whereas other countries use millimoles per liter. For a devices marketed worldwide a technical solution is required.

We hope that the above summary will be helpful. Should you have any questions or require additional information, please do not hesitate to contact us. We will be more than happy to assist you.