Conformity assessment and CE marking of products after placing on the market?
A presentation based on the example of existing machines
The harmonisation regulations contain clear specifications relating to the order in which the conformity of a machine must be ensured and the point in time by which it needs to have been labelled. The circle of economic operators under obligation in this context has also been conclusively defined. Thus there is no room left for the subsequent labelling of a machine that is already in the field by its manufacturer, operator or distributor.
Given the number and diversity of products reaching the European market, in particular via Internet platforms and fulfilment centres, it is understandable that distributors are asking themselves whether it is possible or indeed mandatory for them to label products which reach them without a CE marking retroactively. That question is currently also the subject of keen discussion in respect of machines from the point of view of manufacturers and operators. So our aim here is to present and explain the current legal position looking at the example of machines.
According to the specifications of the Machinery Directive 2006/42/EC (MRL), it is the manufacturer who is responsible for the conformity of a machine. As a matter of basic principle, therefore, the manufacturer is the one who has to make sure that his machine meets the basic safety and health protection requirements that apply to it. He has to carry out a conformity assessment procedure, draw up a risk analysis in which the hazards posed by the machine are conclusively identified and assessed, issue an EC conformity declaration, and finally affix his machine with the CE marking. The circle of those under obligation here in statutory terms is thus closely defined. These responsibilities can only be reallocated if the manufacturer, having no place of business in the EU, engages an authorised representative to take care of these tasks for him.
From the point of view of time too, the MRL lays down concrete requirements as to the order in which the conformity of a machine must be established. Information about this is provided on the one hand by the specifications listed in Annex I of the MRL, according to which the manufacturer must first identify the basic requirements relating to safety and health protection that apply to the machine by means of a risk assessment, and then design and build the machine taking those insights into account. Moreover, Art. 5 of the MRL states that the manufacturer already has to have fulfilled all the obligations listed there before placing the machine on the market, which also includes the conformity assessment and the labelling. There is thus no provision for carrying out these steps at any later point in time, and there is no necessity for it either as long as all the requirements are met.
Moreover, the aim of the European legislators, that of ensuring the safety and health of individuals, in particular workers and consumers and especially in relation to the risks they incur when dealing with machines, must not be ignored either. Thinking logically, it would not be possible to achieve that aim if manufacturers were allowed to place their machines on the market and test their suitability for it before establishing their conformity.
But what does this mean for distributors and operators who are in possession of machines which have not been labelled?
Art. 7 of the MRL covers the rebuttable presumption that a machine which has been labelled with the CE marking and has a correct and proper EC declaration of conformity attached to it complies with the provisions of the Directive. However, that does not necessarily mean that a machine which has been placed on the market without a CE marking does not comply or, indeed, that it is unsafe.
It follows that the question of what obligations are incumbent on the operator of an unlabelled machine can thus be answered primarily from the points of view of industrial and operational safety. According to the requirements of the Industrial Safety Regulation (BetrSichV), a commercial operator is under obligation to identify and assess hazards which could be posed by his machine before using it, and to do so regardless of whether the machine carries a CE marking or not. If necessary, he must derive suitable protective measures from that assessment. For the operator, the use of working materials is thus primarily a question of material safety, not one of formal conformity.
As participating economic operators, distributors make their contribution to the fulfilment of these legislative objectives by placing only safe products on the market. They must not place products on the market which they know or should know to be non-compliant, and they may for this reason be subject to market surveillance measures. In addition to that, they also render themselves vulnerable under the law of competition if they sell machines or other products without a CE marking in spite of their being required to be labelled by law.
To sum up, it can be said that there is no provision for the subsequent labelling of a machine which is already in the field by its manufacturer, operator or distributor.