Myths and reality of the presumption of conformity

1 December 2017

The presumption of conformity is a concept that is widely used in the context of the European “New Approach” better regulation model, which for over three decades has efficiently served the needs of manufacturers as regards the lawful placing of products on the EU Single Market. It has recently gained increased attention following the adoption of Regulation 1025/2012 on European Standardisation. This Regulation codifies the main avenue for manufacturers to benefit from the presumption of conformity: namely, that the design of their products complies with what are termed “harmonised standards”, the titles of which have been cited in the Official Journal of the EU.

Yet, few understand what legal effect this presumption of conformity grants to standards users (typically industrial manufacturers, service providers and their B2B customers), once it has been initiated through the publication of standard titles in the Official Journal of the European Union (OJEU) by the European Commission –under the scrutiny of Member States authorities and the European Parliament.

With the ruling of the Court of Justice of the EU in the James Elliott case C/613-14 last October fuelling more misconceptions around the implementation of the presumption of conformity, Orgalime called on the European Commission to preserve the EU ‘New Approach’ as one of the Single Market’s best regulatory techniques (position paper of 8 March 2017).

Orgalime seeks to clarify the meaning of the presumption of conformity by participating actively in the Action 8 of the Joint Initiative on Standardisation with European Commission officials, CEN, CENELEC, ETSI, and many other stakeholders.

Our purpose is to demonstrate that the presumption of conformity is a legal benefit which stems from the citation of harmonised standards in the OJEU, but which has no effect if manufacturers do not activate it by choice, by designing a product in compliance with applicable harmonised standard(s). Contrary to the European Commission’s allegations, Regulation 1025/2012 has not changed the relevance of the presumption of conformity: it remains nothing other than a means of facilitating the legal acceptance by 28 EU Member States of harmonised products to be placed on their markets.

Consequently when the European Commission takes an approach to the presumption of conformity that treats it not as a potential benefit for private operators but rather as a public ‘liability’ for the Commission itself, this represents a far-fetched interpretation which runs the risk of jeopardising a key facilitation feature of the “New Approach” to technical harmonisation, as was noted by the Court of Justice of the EU in the Global Garden case T 474/15 of 26/01/2017. It could even make the European standardisation system increasingly irrelevant to economic operators. Securing the trust of all stakeholders – whether national authorities, economic operators or customers – in product conformity can only be achieved through other means – in improved market surveillance to start with.



Please download the full article below. However, we would like to note that this article is not a Orgalime position paper.