SHEQ Management System

The single global market concept is something that economists around the world are striving for. The European Union (EU) has taken great strides towards achieving this, and the EU and the European Economic Area (EEA), which includes all EU Member States, as well as Iceland, Liechtenstein and Norway, has made great progress in creating a single market in Europe and elsewhere. They have done this by removing the barriers which are caused by restrictive national legislation and regulations, and replacing it with legislation and regulations issued by the European Parliament.

The way that the barriers were removed was through the creation of the "New Approach" to product regulation and the "Global Approach" to conformity assessments. These approaches limit public intervention to only what is essential, and leave business the greatest possible choice on how to meet their public obligations.

Since 1987 a number of EU Directives have been adopted by the EU and its Member States to help this process along. The requirements of these directives are included in the national legislation and regulations of each Member State.

Under the directives, product standards have been "harmonized" between the Member States, eliminating the problem of national standards creating barriers on the basis of different standards in different states. New standards are adopted by all the member states, creating a level playing field throughout the EEA.

This approach was so successful that the standards are being adopted in countries outside the EU through their standards organizations, including in South Africa, where a number of these standards have already been adopted. Individual customers worldwide are specifying compliance to the EU directives as a requirement to their suppliers.

The national technical regulations of Member States of the EU are now subject to articles 28 and 30 of the EC Treaty. The treaty prohibits quantitative restrictions or other restrictions which would limit trade activities between the states.

To prove compliance with the applicable directives and standards, the CE Marking is applied to products. CE stands for "Conformité Européene". Once the CE Marking has been applied Member States assume compliance and the products can be placed on the market in the EEA. This provides for the free movement of goods in the EEA.

The benefits for the manufacturer lie in the fact that the EEA becomes open as a potential market. There is only one set of laws and regulations to comply with.

What does the CE Marking and compliance actually mean? It means that the product complies with all the health and safety requirements for the product. The product is thus safe to use by the consumer (the risk assessment also looks at 3rd party safety). Environmental issues are also addressed, but do not form the main focus of the application.

To be able to apply the CE Marking the manufacturer must prove compliance with the essential health and safety requirements. Sometimes it is as easy as putting together the required technical file, proving compliance (a risk assessment is normally also carried out to estimate the acceptability of the risks that are present) and then making a self declaration of compliance. In the case of more dangerous products the services of a Notified Body (an organization "notified" by the commission of its status as a Notified Body) is required, who will assess compliance, and, if satisfied, will issue an EC certificate as proof of compliance.

It is essential to realize that there are severe penalties for falsely applying the CE Marking to a product. There is a safeguard clause in each directive that obliges Member States to take all appropriate measures to prohibit or restrict the placing on the market of products bearing the CE Marking, or to withdraw them from the market if already there, if the product might compromise the safety and health of individuals and other public interest covered by the applicable directive. In such a case the Member State is required to notify the appropriate commission, who will in turn notify all other Member States. There are severe financial implications involved. Note that this only applies if the products are used according to their intended purpose. Member States are obliged to conduct "market research" on products that are on the market in their state to ensure that those products comply.

This leads to the bad news for the manufacturer: The directives may require that additional health and safety measures are needed on the products (above and beyond those that would normally be applicable in the country of origin). This will increase the manufacturing cost. There may also be the cost of the services of a Notified Body, as well as the cost of testing in accordance with applicable standards. If the organization is not familiar with the directives (sometimes more than one may be applicable) and with the compliance routes, it can cost a lot in time and error before the requirements are clear and the actual declaration can be made.

When a product bears the CE Marking it symbolizes the conformance to the applicable community requirements imposed on the manufacturer. It is a declaration by the responsible person in the organization that the product conforms to all the applicable community provisions, and that the appropriate conformance assessment procedures have been completed.

How does the CE Marking impact on South Africa? The first and the most obvious impact is that products exported to EEA countries must comply with all the requirements, and, where applicable, bear the CE Making.

The second impact is that South Africa has, through the SABS, adopted many of the harmonized standards. Where this is the case, compliance with the standard requirements should be easier, since products manufactured for the South African market also have to comply with these standards.

A third, relatively new impact is the consideration at government level to apply the requirements of the European Medical Devices Directive as is as the mandatory requirements for regulation of medical devices in South Africa. This will apply to devices manufactured in South Africa, as well as those imported into the country. Is this possibly a sign of things to come?

But it is worth noting that compliance with European Harmonized Standards for the European market is voluntary, if the manufacturer can prove compliance with all the essential health and safety requirements in another way.

SHEQ Management Systems can assist organizations which require information or assistance regarding the application of CE Marking to their products. We will help to make the process as easy as possible. Organizations will have access to expert advice on compliance with the relative directives so that the CE Marking can be applied with confidence to their products.