Manufacturers of radio equipment are not required to supplement the CE marking with the identification number of the manufacturer’s official testing body if the product, according to the manufacturer, has been manufactured in accordance with an EU-harmonised standard.
Read attorney Hans Sønderby Christensen’s article published on Monday, 22 October 2018, on Jyllands-Posten’s website here.
In a new judgment, the EU Court of Justice establishes that manufacturers are not required to supplement the CE marking with the identification number of the notified body if the product group has been manufactured in accordance with a harmonised standard, as there is a presumption that the product complies with the essential requirements for the product’s design. Although it appeared from the wording of the legislation that the identification number should be affixed, the EU Court of Justice ruled that the provisions should be interpreted in conjunction with the entire legislation, and therefore the identification number should not be affixed if the harmonised standard, according to the manufacturer, has been complied with.
In EU law, CE marking plays a significant role in protecting the free movement of radio equipment. At EU level, requirements have been laid down that certain product types must be CE-marked, while for other product types it is optional. The requirement for CE marking applies, among other things, to toys and radio equipment. When a product is CE-marked, it can be sold throughout the EU without the Member States being able to impose further requirements for documentation of safety. The free movement of products is a priority area within the EU, and it is therefore an area that companies should be aware of and take into account. A manufacturer who affixes a CE marking to its product thereby declares that the product meets all relevant requirements for the CE marking. Within the EU, a number of European standards have also been drawn up, including the harmonised standards, which are of decisive importance for the manufacturer’s implementation of the CE marking. These are standards – and guidelines – for how a manufacturer meets the requirements of the legislation. Depending on the products in question, compliance with the harmonised standards may mean that the product does not have to be approved by a notified body. The EU Court of Justice’s decision in this case concerns precisely the relationship between CE marking and the application of a harmonised standard.
The case arose from a dispute between the Italian company COBRA and Ministero dello Sviluppo eco-nomico (the Ministry of Economic Development, hereinafter MISE), which was authorised to carry out checks on this type of product in Italy. The dispute concerned the lack of affixing of the control body’s identification number on equipment manufactured by COBRA. COBRA is a trader in consumer electronics and markets, under the Pascal trademark, a repeater system for home use, which is installed near an audio or video source, which picks up and forwards the signal for playback on a TV placed at a distance of up to 100 m. During an inspection in 2011, MISE found that, as far as the Pascal equipment sold to consumers was concerned, the control body’s identification number was neither printed on the equipment nor on its packaging, but only appeared in the instructions for use supplied with the equipment. MISE seized the equipment and also imposed a fine on COBRA. COBRA was also ordered to bring the seized copies and those already marketed on the Italian market into conformity with the requirements for the affixed identification number.
COBRA brought the case before the Tribunale amministrativo regionale per il Lazio (the Regional Administrative Court for Lazio, Italy), which ruled in favour of MISE, as this court found that the EU rules imposed on MISE the responsibility for conformity control. The case was subsequently brought before the Consiglio di Stato (Supreme Court in administrative cases, Italy), which found that it was both illogical and contrary to the principle of proportionality to impose the intervention of a control body when harmonised standards were available, and the Italian court therefore referred the question to the EU Court of Justice.
EU law requires that the identification number of the notified body is, in some cases, affixed as a supplement to the CE marking. For the product type – radio equipment – a harmonised standard has been drawn up. If the manufacturer follows the requirements in the harmonised standard and carries out the tests of the equipment required therein, the equipment can be affixed with CE marking without approval by the notified body, as the body must adhere to the presumption rule that the equipment is safe. The question for the EU Court of Justice was whether the equipment should also be affixed with the authority’s identification number when it had been manufactured in accordance with a harmonised standard, and had therefore not been subject to control by the notified body.
The EU Court of Justice initially stated that, when interpreting provisions in EU law, account must be taken both of the wording, but also of the context in which they are included and the objectives to be achieved with the rules. Seen in this context, the wording of the provision on CE marking could in itself give the impression that EU law required the CE marking to be supplemented with the identification number of the control body. However, it appeared from the annex to the provision that the control body’s intervention in the manufacturer’s procedure for CE marking was not required in all cases. An equipment’s compliance with the essential requirements could be demonstrated by the manufacturer himself if he had fully complied with the requirements laid down in the harmonised standards. On this basis, the EU Court of Justice ruled that a manufacturer could not be required to supplement the CE marking with the authority’s identification number if the harmonised standards had been complied with. The EU Court of Justice further noted that the opposite interpretation would mean that the control body would have to intervene in a situation where the equipment’s compliance with the essential requirements in EU legislation is already presumed to be met.
The EU Court of Justice concluded that, in these cases, where the presumption of correct compliance with EU rules was present, the control body’s intervention was not necessary with regard to ensuring users’ health and safety. This is supported by the fact that the control body’s function is precisely not to control all equipment’s compliance with the requirements in EU law, but instead to control manufacturers’ procedures. The EU Court of Justice added in this connection that, also in those cases where a manufacturer of its own accord consults the body with a view to obtaining confirmation of the content of the essential requirements in the harmonised standards, the manufacturer is not obliged to affix the identification number.
The EU legal regulation of when control bodies can impose requirements for marking with an identification number as a supplement to CE marking on radio equipment has been changed since the question was submitted to the EU Court of Justice. The new rules, which have been applied since 16 April 2014, have, however, not led to changes in relation to the judgment’s conclusion, as the control bodies still cannot impose requirements for marking with an identification number on manufacturers who fully apply the harmonised standards.
With this judgment, it has therefore been established that control bodies for product groups where requirements for CE marking have been introduced, and where there are harmonised standards that are fully followed, have no claim to further control or marking with their identification number. If the manufacturer’s procedure is in accordance with the harmonised standards, it naturally follows that there is a presumption that the manufacturer complies with the EU rules. Further control will therefore not be in accordance with other EU principles or legislation.
It should be noted that, in those cases where a manufacturer has not used, has only partially used, or if harmonised standards do not exist for a product group, a control body can still, under certain conditions, impose requirements for further marking with an identification number.