When I set out to investigate this question, I would not have guessed that it would turn out to be as much of an odyssey as it did. For most products, determining the need for a CE Mark is relatively straightforward, but not for wire and cable products! As equipment designers, engineers and technologists, we rarely think much about wire and cable. We’re mostly concerned with the insulation colours, number of conductors, the gauge and the voltage rating. Sometimes we’re also concerned about the temperature rating, the flexibility, or perhaps the shielding. The regulatory approvals carried by the wire are often assumed, or not considered at all. This common product can bring a world of headaches if the requirements are not fully considered.
The compliance assessment procedure of certain products with the Europeans standards, as laid down in their corresponding EU directive, may involve the notification of third-party, independent bodies. In the EU, such organisations are called Notified Bodies and their role is to evaluate whether the product complies with the relevant legislation in force.1) In this article I will discuss what the role and responsibilities of a Notified Bodies are.
The European Chemicals Agency (ECHA) made public in a press release from September 10th 2013 that 3,215 companies had submitted 9084 registration dossiers by the 31st May 2013 deadline. Additionally, 270 dossiers linked to the 2013 deadline have been received by the agency since then. ECHA assessed the completeness of all submitted dossiers by 31st August, after which it granted registration numbers to 9,030 dossiers.
An investigation by the European Chemicals Agency (ECHA) has uncovered that of a total of 1 181 companies inspected, 67% did not comply with one or more provisions of obligations under REACH and rules on the classification, labelling and packaging (CLP) of chemicals. This dramatic non-compliance percentage shows that there is still a lot of work to be done in training and in enforcement in order to improve the performance.
The ECHA Forum’s second enforcement project (REF-2) focused on checking the compliance of downstream users – particularly formulators of mixtures – with the essential requirements of the REACH and CLP regulations. This enforcement project promoted a level playing field through the harmonisation of enforcement approaches in the Member States and fostered cooperation between inspectors. It was carried out in 29 Member States or EEA countries.
The project’s operational phase was carried out from May 2011 until March 2012. The national enforcement authorities inspected 1 181 enterprises covering 6 900 substances, 4500 mixtures and 4500 safety data sheets (SDSs). The majority of the inspected companies were small or medium-sized. More than half of the inspected companies were not only active as downstream users but also in additional roles, e.g. as manufacturers, importers, distributors and only representatives.
In 2007, the EU introduced new rules for the chemical industry — the REACH package — are set to improve our health and protect the environment. Obliging companies to register and provide information on the chemicals they use should enable public authorities to identify their properties more quickly and accurately. Particularly severe on toxic products, the new rules will encourage the European chemicals industry to develop new substances that are less harmful for people and the environment. As a result, the sector itself should also gain a lead in innovative and sustainable technologies.
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