Nemo censetur ignorare legem: the dilemma regarding the access to ISO standards referenced into EU law, by Marie Gérardy

EU public actors increasingly use copyright-protected private technical standards in the operationalisation of EU law. This post suggests that the responsibility to work out the tension between the right to know the law and the right to intellectual property enjoyed by private standard-setters is incumbent upon the EU public actors. Compensation in the form of a contribution to the annual budget of standard-setters for each standard referenced in EU law in exchange for public access will be proposed.


Imagine a world where public health policy and the regulation of cigarettes would be partly in the hand of the tobacco industry itself, and available only against payment. ‘Impossible’, many would say, ‘not in a legal order built on the rule of law!’. And yet, here is but one example: EU law caps cigarettes’ emissions and requires that, in order to access the EU internal market, emissions be calculated based on ISO 4387, ISO 10315, ISO 8454 and ISO 8243. The measurement methods contained in these copyrights-protected technical standards, have been developed by an ISO committee that is predominantly composed of CORESTA members. The latter is an organisation that gathers powerful private actors from the tobacco industry.

EU public actors often and increasingly rely on private technical standards in product regulations. They do so to facilitate the free movement of goods as well as to fulfil their international trade law obligations which, for the sake of reducing technical barriers to trade, require states to base their regulations on international standards. Moreover, the use of technical standards in EU law provides for an expert-based and flexible complement to traditional policy-making which faces difficulties coping with technical aspects anchored in complicated transnational supply chains. However, the threat to the democratic legitimacy of this embedding process is real. It equips private actors with the capability to adopt private instruments yielding law-like effects by determining market access as well as operationalising public policies. This entanglement of public and private interests in technical standardisation raises several issues like the following: Can the EU legislator refer to private technical standards protected by intellectual property rights in EU law without publishing their content in the Official Journal of the Union?

It was only a matter of time before this question, which seems to oppose the constitutional necessity to know and have access to what constitutes the law to the private standard-setters’ right to intellectual property, would be raised in front of the Court of Justice of the EU.  After shortly reviewing the EU legal framework on the matter as well as the position of AG Saugmandsdaard OE in case-160/20 (the judgment is not yet out), this post suggests that both objectives are perhaps not irreconcilable. The dogmatic distribution of responsibilities in light of the functions and the roles played by each actor involved should, however, be slightly revamped. In that regard, the deliberate choice of the EU legislator to rely on private instruments protected by IP rights in its policy-making will be underscored.

Legal framework

According to the adage “nemo censetur ignorare lege”, there exists a constitutional imperative to know the law.  Knowing the law requires it to be publicly accessible.  Such access allows citizens to be aware of and, thus, to be able to comply with the law. But it also allows stakeholders to exercise democratic scrutiny over fundamental policies which concern the public interest. In that regard, art. 15 TFEU requires that every EU citizen has access to the content of legislation. To ensure such access, art. 297 TFEU prescribes the publication of all legislative acts in the Official Journal of the EU. Finally, Reg. 1049/2001 specifies in further detail the right of direct access to documents of the institutions, albeit subject to exceptions.

This has to be contrasted with intellectual property rights enjoyed by private undertakings investing in research and development aimed at creating technical standards. The EU undertook to base its regulations on existing international standards under the SPS and TBT agreements as well as various bilateral trade deals. These relevant international standards are protected by copyrights granted under national law and further safeguarded by international legal instruments such as the Berne Convention. In that regard, Reg. 1049/2001 provides that the right of access to documents can be restricted when the disclosure of a certain document would result in undermining the protection of “commercial interests, including intellectual property rights”. The protection of intellectual property rights is also enshrined in the EU Charter of Fundamental Rights and so is the right to conduct a business. Both rights are essential to upholding the economic incentive to develop technical standards and to ensure the overall efficiency of the process.

AG opinion

AG Saugmandsdaard OE is of the opinion that the referencing of ISO standards in EU law without publishing their content in the OJ does not constitute a breach of art. 297 TFEU nor of the principles of access and transparency. Here is why.

According to him, ISO standards referenced in EU law are not a legislative act under art. 289 TFEU nor do they constitute an element of a legislative act and do not, therefore, fall under the obligation of art. 297 TFEU. Instead, ISO standards constitute ancillary technical precisions that are merely accessory to the essential requirements, i.e. the emission thresholds, laid down in the tobacco directive. In his view, the fact that cigarettes cannot be put on the market if the emission levels are higher than the ones foreseen by the legislator is what determines market access and, thus, what should be publicly available. The measurement methods prescribed by the ISO standards would only be binding on the certification laboratories and would not seek to impose obligations onto the companies whose products are concerned by the directive.

Rather, the AG argues, ISO norms represent only one method to comply with the law and, in that sense, have a similar function to European harmonised standards which grant a presumption of conformity with EU law. Based on this comparison, he further reasons that, since the court did not address ex officio the matter of access and publication of harmonised technical standards in the OJ in James Elliot, there probably is no legal issue in the case of ISO standards being referenced in EU law either.

When it comes to copyright protection, the AG affirms that the ISO depends financially on the fees it collects for its standards as well as its membership fees which themselves depend on the national copyrights. After acknowledging that ISO standards are fundamental to the well-being of the internal and global markets as well as to our daily lives, the AG argues that granting free access would endanger the functioning of the ISO and in turn, threaten all these efficiencies. Finally, he insists that the restriction on the right to access is not disproportionate since ISO standards are publicly accessible against the payment of a reasonable fee and it is possible to consult them at specific places free of charge. The Dutch Standardisation Organisation offers such a possibility for instance.  

Importantly, the AG makes no mention of the hybrid complex legal nature of these technical standards nor the responsibility of the EU legislator on the matter.


Clearly, the AG opted for an “either/or” formal approach: either an instrument is law formally and should therefore be freely accessible or it is not law and should thus fall into the ambit and the protection of private economic law. By doing so, he missed a chance to address an important legal lacuna: the instrumentalisation of private tools, which are inherently loaded with private economic interests, in the operationalisation of EU law. It is not because a hybrid legal phenomenon is not formally described in the treaties that its legal effects are not real.

First of all, his argument that ISO standards referenced in EU law do not constitute legislative acts nor part thereof should leave one perplexed. Formally, it might certainly be true. After all, ISO standards are developed privately within an ISO technical committee without going through the usual democratic legislative process. One could retort that the ISO standards at stake have been explicitly referenced in the text of law by the EU legislator after going through such a process. Functionally, however, his reasoning is hardly persuasive. The AG indeed argues that ISO standards do not constitute an essential element of the law since they do not, in fact, impose any obligation onto companies but rather mere technical specifications to the actual essential legislative element, namely the maximum levels of cigarettes emissions.

First, the emission thresholds are only one aspect of the essential obligation contained in the law. The framework, method, and procedure contained in the ISO standards and prescribed by the directive to demonstrate whether cigarettes are compliant with the said threshold also constitute a prerequisite to market access. This is because no undertaking would take the risk to go through a costly and lengthy certification procedure without safeguarding a chance of success at market access. Thus, it does not matter whether the standard is binding on the certification labs and not directly on the companies. The result is the same: the producer wishing to enter the market needs to comply with the private technical standards at one point or another. Furthermore, it does not matter at which point in time the standards become binding and on which actor precisely: the fact that the standards are only available at a cost frustrates the stakeholders’ right of access, transparency and scrutiny. 

Second, the measurement methods contained in the ISO standards have been highly criticised by the scientific community en masse, as they appear to provide unreliable and deceptive results. It seems that the measurement methods produce lower content emissions than the ones actually inhaled by the consumers because the holes on the cigarette filters, usually covered by smokers’ fingers, are not considered in the measurement method prescribed in the ISO standards. That leaves one with two important hints. First, since the ISO standards seem to distort the actual levels of emission capped by the directive, it is evident that the method of measurement is as essential as the thresholds foreseen by the legislator in the law. Second, if the technical standards at stake were freely accessible, certain actors of civil society could have the chance to spot and denounce these inaccuracies more efficiently.

ISO standards referenced in EU legislation should thus be considered as an essential part of EU law and be made accessible. Does it mean, however, that standard-setters should not be able to rely on the exception under art4(2) Reg.1049/2001 to protect their commercial interest?  The answer is negative. The AG rightly defends that ISO standards are worthy of intellectual protection since they constitute creative inventions. In another recent and related case, (Case T‑185/19, Public.Resource.Org, Inc., and Right to Know CLG), the General Court argues that the fact that the CEN (European standard-setter) is involved in tasks of public interests does not alter the notion that, initially, it is a private undertaking engaged in private economic activities whose commercial interest should be protected. Furthermore, the court concluded that free public access to CEN deliverables would ‘undeniably impact CEN’s intellectual property’ (para 67).

This is all the more so when it comes to ISO standards directly referenced into EU law. ISO, although it benefits from the visibility of being referenced by public actors, does not enjoy any sort of public mandate, unlike the CEN. Its subsistence relies exclusively on the royalties collected from IP rights and private memberships. Contrary to CEN, ISO is not subsidised by the European Commission. Furthermore, the EU legislator does not have the jurisdiction to deprive private actors of intellectual property rights granted by national law.

All in all, ISO standards referenced in EU law are private inventions worthy of intellectual protection which, however, form an essential part of EU law and should therefore be accessible to the public. This complex legal conundrum has arisen because of the regulatory system designed and endorsed by the EU legislator itself. While the matter is complex, some solutions can, at least partially, balance the competing interests it raises. Compensation in the form of a contribution to the annual budget of the ISO could be envisaged for each ISO standard that the EU legislator decides to use for the operationalisation of EU law in order to cover ISO’s intellectual property rights. This would permit ISO to grant public access to these standards without losing the incentive to develop them.


ISO standards initially have a recommendatory voluntary nature deprived of any de jure binding force. The embedding of these technical standards into EU law, however, significantly blurs the boundaries between hard law and soft law and the summa diviso between private law and public law since it equips private orderings with the capability to produce legal effects for third parties. The higher the normative strength of an instrument, the more rigorously it should be accessible. If the technical standard is only an option, amongst others, to comply with a piece of legislation, then the reasoning of the AG is sound since the standard only represents a non-binding technical precision. If, however, as is the case here, the technical standard is the only means to comply with the law and to have access to the market, it should then be made freely accessible, especially if it concerns public policy issues such as health and the environment.

Be that as it may, it does not mean that the issue of access is the sole burden of private standard-setters. They obviously benefit when their technical standards are embedded into public law since they gain visibility and become indispensable for market access. In light of their tremendous impact on the markets, public regulation, and people’s daily lives, technical standard-setters undeniably carry a responsibility to consider the public interest to a certain extent. However, it should also not be a reason to erode their efficiency. Systematically depriving them of their intellectual property rights would have broad consequences. Technical standards are indeed indispensable to the functioning of the internal and global markets and provide a necessary complement to traditional law-making which lacks expertise. Fundamentally, it is the choice of the EU public actors to refer to these standards and they should thus bear the financial and democratic responsibility of such a decision by granting public access to these ISO standards to EU citizens as well as compensating ISO for its loss.

Posted by Marie Gérardy

Marie Gérardy is a PhD candidate in European Law at the University of Luxembourg under the supervision of Prof. Dr. Joana Mendes. After completing a double bachelor degree in European and Dutch law at Maastricht University, she obtained her Master’s degree in international law (Maastricht University) and her LLM in competition law and economics (Brussels School of Competition). During her university curriculum, Marie was a trainee at the European Parliament and at the European Standardisation Organisations. Prior to joining the University of Luxembourg, she was a university lecturer in European administrative law at the University of Maastricht. Her research focuses on the embedding of private technical standards into EU law and the resulting public and economic law consequences of such co-regulatory and hybrid mechanisms. 

Suggested citation: M. Gérardy, ‘Nemo censetur ignorare lege: the dilemma regarding the access to ISO standards referenced into EU law’,, accessible at