Harmonised European Standards and the EU Court of Justice: Beware Not to Open Pandora’s Box
By Bardo Schettini Gherardini
As already stressed by Megi Medzmariashvili in her post of 1st March 2016, the question of whether the Court of Justice of the European Union (‘the Court’ or ‘CJEU’) has jurisdiction to give a preliminary ruling on the interpretation of a harmonised technical standard (‘HTS’) adopted by the European Committee for Standardisation (‘CEN’) is, for the first time, raised in Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited.
As Director – Legal Affairs of both CEN and CENELEC (the European Committee for Electrotechnical Standardization), I would like to give an insider’s view on the European standardization system and to expose a more critical approach to the Opinion delivered by the Advocate General (‘AG’) Campos Sanchez-Bordona on 28 January 2016. The AG suggested, in reference to the first question referred for a preliminary ruling, that the Court must declare that it has jurisdiction for the main reason that the HTSs should be regarded as acts of the institutions, bodies, offices or agencies of the Union for the purposes of Article 267 of the Treaty on the functioning of the Union (‘TFEU’), which is the primary law basis of the cooperation between the CJEU and the national courts via the preliminary ruling system. The opinion of the AG is based on three arguments that I would like to comment on, just after insisting on some essential elements of background on the way HTSs are produced and how CEN and the other European standardisation bodies are working.
Harmonised Technical Standards are documents of voluntary use
In the context of the European single market, CEN and CENELEC have adopted around 20.000 TSs as of today, including around 5.000 HTSs. All European standards, including HTSs, are voluntary tools of the market. The voluntary use of standards is promoted both at international and at EU level: the WTO Agreement on Technical Barriers to Trade in its Annex 1 clearly distinguishes standards from ‘technical regulations’ as it recognises that standards are voluntary in application whereas technical regulations are mandatory. This essential difference has been accepted and promoted by the European authorities for many years (see Article 1.4 of DIRECTIVE 98/34/EC of 22 June 1998) and it is still recognised by the recital (1) of Regulation (EU) No 1025/2012, which states: ‘The primary objective of standardization is the definition of voluntary technical or quality specifications’.
Hence, if the European legislator sets the legal so-called “essential requirements”, which all economic operators have to meet – whether they are using harmonised standards or not – to ensure free circulation of their products on the Single Market, it leaves to CEN, CENELEC or ETSI (i.e. the recognised European standardization organizations (ESOs)) to develop voluntary standards that can give technical solutions, accepted by the relevant industry, to ensure compliance with these essential requirements. The important aspect of this kind of public-private partnership is that if a company decides to use the HTS, it will benefit of a presumption of conformity to the essential requirements set in the relevant legislation. However, nothing will prevent the same company from demonstrating such conformity of its product otherwise without using the HTS. The voluntary nature of HTS is indeed one of the main principles of the so-called “New Approach”, followed by the legislator in more than 30 Directives and Regulations.
Harmonised Technical Standards are not EU acts within the meaning of Article 267 TFEU
The first argument developed by the AG is that “[t]he use of the new approach directives may not compromise the Court’s jurisdiction to give preliminary rulings” (see para. 42-45 of the Opinion). In that regard, an apparent logical link is established between the fact that, on one hand, the CJEU has jurisdiction to give a preliminary ruling on the interpretation of Directive 89/106 and, on the other hand, the fact that the HTSs are supplementing that Directive. Otherwise, said the AG, the harmonisation of construction products would be rendered “ineffective”, as the HTSs “could be given diverging interpretations in the various Member States”.
I do not think that this is the right way to tackle the issue relating to the scope of Article 267 TFEU in terms of acts to be interpreted by the Court: the very wording of this provision does not include any criteria related to the fact that an act supplementing an EU act may fall in its scope.
Should such extensive construction of Article 267 TFEU be confirmed by the Court, any national act implementing, for example, an EU directive, might be referred to the CJEU for a preliminary ruling. This is not consistent with a well-established case-law according to which the Court “has no jurisdiction to decide whether the interpretation given by the national court of provisions of national law is correct or to give a ruling on the conformity of those provisions with [EU] law. It is the task of the Court solely to interpret provisions of [EU] law in order to give the national court all the guidance on matters of [EU] law that it needs in order to decide the case before it” (see, inter alia, Case C-58/98, Corsten, para. 24). Indeed, the only relevant criterion is the qualification of the act as a provision of EU law. Besides, to apply such qualification to HTSs also implies to recognise the qualification of their author (e.g. CEN) as “institutions, bodies, offices or agencies of the Union”, terms used by Article 267 TFEU.
European Standards Organisations are not institutions, bodies or agencies of the EU
That leads to the second and the third argument developed by the AG: without explicitly assuming that CEN is an institution, a body or an agency of the EU, the subsequent reasoning has the same effect because: first, “[t]he Commission exercises significant control over the procedure for the drafting of harmonised technical standards by the CEN” (see para. 46-55 of the Opinion) and, second, “[t]he operation of the CEN as a standardisation body is subject to action by the European Union” (see para. 56-62). These two statements deserve a joint analysis.
Regarding the control exercised by the Commission, it must be underpin that such control is more relative than “significant” for the following reasons: 1. Regulation n°1025/2012 does not require any formal ex-ante check by the Commission before the publication of a HTS in the Official Journal of the EU (see Article 10.6); 2. in case the Commission decides not to publish the reference of the HTS adopted by CEN in the Official Journal, this standard remains valid and still may be used by the economic actors on a voluntary basis; and 3. in case a Member State or the European Parliament may lodge formal objections regarding compliance of the HTS with the requirements which it aims to cover (see Article 11 of Regulation n°1025/2012), such an objection cannot be considered – per se – as the expression of a “controlled legislative delegation in favour of a private standardisation body”, as suggested by the AG (see para. 55 of the Opinion).
Indeed, the exercise of legislative delegation is strictly construed by CJEU case-law (see Case 10/56, Meroni v High Authority and Case C-270/12, UK v European Parliament and EU Council) as, inter alia, only clearly defined executive powers may be delegated and, once again, such delegation is reserved to bodies or agencies of the EU, not to private bodies like CEN, which has not the power to adopt EU acts of general application within the meaning, in particular, of the first paragraph of Article 263 TFEU and Article 277 TFEU.
It is precisely for this last reason why the argument referring to the fact that CEN is subject to action by the EU is not valid, and the elements put forward by the AG to support this argument are not convincing.
A first element invoked by the AG is the existence, since 1984, of agreements in form of General Guidelines for the Cooperation between CEN, CENELEC and ETSI and the European Commission and the European Free Trade Association. However, these Guidelines only draw common policy objectives and principles of relationship and cooperation, as well as the main expectations from the European Standards Organisations (‘ESOs’) vis-à-vis the Commission. There is definitively no reference to some power of instruction or delegation of powers from the Commission to the ESOs. Cooperation is not, in the present case, subordination and does not confer to CEN the qualification of an EU body, within the meaning of Article 267 TFEU.
A second element raised by the AG is the financial support given by the Commission to the ESOs for the drafting of HTSs, as organized by Decision n° 1673/2006/EC of the Commission. It must be recalled that such financial support in 2015 has been equivalent to only 15% for CENELEC and 35% for CEN of their yearly budget devoted to the activities of their Brussels management centre and, as the AG himself recognises, “industry assumes the greater share of the costs of standardisation” (see para. 58 of the Opinion). Stated differently, CEN (and CENELEC) are not financially dependent on the EU financing. Furthermore, once again, there is no reference at all in this Decision to some power of instruction or delegation of powers from the Commission to the ESOs. Similar to the cooperation aspect, financial support is not, in the present case, subordination and does not confer to the CEN the qualification of an EU body within the meaning of Article 267 TFEU.
Moreover, I have some reservations regarding the specific relevance of the statement that “[t]he private nature of standardisation bodies (in this case, the CEN) does not mean that their activities fall outside the scope of EU law” (see para. 59 of the Opinion). While this is theoretically correct, I believe that such statement is simply not the issue at stake. Otherwise, if we accept to follow this approach, quod non, any private body exercising an activity within the scope of EU law would have to be considered as an EU body within the meaning of Article 267 TFEU. Besides, the AG refers to the travaux préparatoires for Regulation n°1025/2012 (see footnote 44 of the Opinion) to underline that the idea of creating an executive agency for the adoption of the technical standards required by the new approach directives has been rejected. That seems to confirm that the option of an “EU institutionalization” of CEN has been discarded and that it is clearly not a EU body. Furthermore, the AG’s reference to the Grimaldi and Gauweiler cases also support this opinion: only acts, whatever they are, adopted by an EU institution (like a recommendation from the Commission in the first case, and decisions of the Governing Council of the European Central Bank, in the second case) are concerned by Article 267 TFEU.
Last but not least, the same reasoning must prevail regarding the fact that HTSs are producing “legal effects in the internal market” (see para. 62 of the AG Opinion): National bodies, either public or private, adopting (voluntary or compulsory) acts with legal effects in the internal market cannot be considered EU bodies within the meaning of Article 267 TFEU. Otherwise, any national technical regulation or specification which “may create obstacles to the free movement of goods within the internal market”, as referred to by Directive (EU) 2015/1535 (see Article 6), might be referred to the CJEU for a preliminary ruling by a national judge, contrary to the current case-law already referred to above delimitating the scope of Article 267 TFEU to EU provisions and excluding national ones.
Conclusion: striking the right balance
As written in Article 5 of the General Guidelines for the cooperation between the ESOs and the Commission of 28 March 2003, “a transparent legal and political framework for European standardisation as an independent, consensus-oriented and voluntary activity” is a crucial requirement for the success of the entire standardisation process in the interest of the EU internal market. Consequently, the current balance obtained between industry involvement and EU public interest, consisting in a process organised by and for the stakeholders concerned, must be preserved. Paving the way to a re-qualification of the ESOs as EU bodies and of the HTSs they adopted as EU acts, even only for the purpose of preliminary rulings from the CJEU, may not only have an impact on such a balance by introducing another institutional perspective (ESOs as public actors and no longer private ones?) but also open Pandora’s Box (of Article 267 TFEU) for any other private activity connected to EU Law.
It was very interesting to read an insider’s view on this topic. With all due respect, I would like to argue for a different understanding of the AG’s opinion. First of all, this post is an example of the existence of the competing views concerning the legal nature of the THSs. On the one hand, the European standards organisations are convinced that the THSs are private voluntary rules, products of private regulation. On the other hand, it is common in the legal scholarship to understand co-regulation via European standardisation as a delegated rule-making. That position now seems to be shared by the AG Sanchez-Bordona.
I read the AG’s opinion proposing THSs to be EU acts, not because CEN is an institution, body or agency of the EU, but rather because of regarding the THS as an act of the Commission. It is due to the Commission’s action that the THSs are adopted. Particularly, the THSs are adopted on the basis of the Commission’s mandate which delegates rule-making power to one of the European standardisation organisation. In addition, the Commission accords the legal effects and grants the presumption of conformity to the THSs by publishing the reference in the official journal. I disagree with the view that Regulation 1025/2012 does not require any ex-ante control. Article 10.5 of that Regulation explicitly states that: ‘…The Commission together with the European standardisation organisations shall assess the compliance of the documents drafted by European standardisation organisation with initial request’. Even more, according to Article 10.6 of the same Regulation: ‘Where a harmonised standard satisfies the requirements which it aims to cover… the Commission shall publish a reference of such harmonised standard…’ This means that prior to publication of the reference, it should be established that the THS satisfies the requirements of the corresponding Union harmonisation legislation. Whether the Commission exercises this prior control or how effective it is, it is another matter.
Concerning the delegation point, the fact that the EU case-law does not allow delegation of general rule-making power to private bodies, does not exclude that such delegation still takes place in practice. Contrary, it could be argued that mandating the adoption of the THSs which are used for legislative purposes is an example of that and thus is at odds with Meroni doctrine.
First of all, thanks a lot to Mrs Medzmariashvili for bringing our attention to this ECJ Court case in her first post of 1st March.
I would like to bring some support to Mr Schettini’s views from a slightly different angle, based on my lengthy experience of working for an industry that is by far the primary users of standards developed by the CEN and CENELEC under New Approach legislation, now codified under the New Legislative framework (Regulation EU 1025/2008 and Decision 768/2008/EC).
The present reply is written by me privately and therefore is not the position of my employer (Orgalime) where we are analysing the impact that the possible judgement of the ECJ could have on the New Approach as Mrs Medzmariashvili correctly stated it in her first post.
Firstly the case revolves around the Construction Products Regulation (CPR), which is not a typical ‘New Approach’ directive or regulation since the CPR, while dealing with products, is faced by the reality of national building regulations, which differ considerably from Member State to Member State. Yet the arguments raised by the Advocate General are generalising a reasoning, which in my view could better match the reality of the use of European harmonised standards in the framework of New Approach legislation, in place for more than 40 years.
Secondly, Mr Schettini’s point is that standards are not are not rules in the same meaning as the law. It is not a conviction, it is a reality: all manufacturers in the EU benefit from the free movement of goods entrusted to their products by the Treaty (Article 28 TFEU), whether they are using harmonised standards or not. It is a matter of equity before the law.
Therefore, harmonised standards cited in the OJEU are not the extension of the law; they are a tool whose use results in a legal facilitation to demonstrate compliance with the law.
A manufacturer that would not use a harmonised standard is still entitled to place their product on the market, as much as a European citizen enjoys the right to circulate freely within all EU Member States, provided that he can show evidence of their citizenship by various means depending on their country of origin.
Thirdly, I would dispute the interpretation that standardisation is ‘co-regulation’, because the EU legislator has not entrusted European Standards Organisations (ESOs) with the use of their privilege to set an acceptable level of risks for all stakeholders in the society, whatever the EU regulatory purpose (health and safety, environment protection, energy efficiency, etc…). Furthermore, how could ESOs accept such responsibility from the EU regulator? Their private organisation and membership have no authority on those that are actually participating in technical committees to develop standards; indeed most ‘standardisers’ are company experts on the pay role of their respective employers; they participate voluntarily in standardisation work for they see an interest for their very own business, not necessarily for society as a whole.
Given this reality, how could technical harmonised standards be considered as an ‘act’ of the European Commission?
Fourthly, the extent of the control granted by Regulation 1025/2012 to the European Commission (EC) – as an execution body, not anymore as a regulator –, is to verify that the harmonised standard respect the law, and therefore could grant the legal facilitation to demonstrate conformity with the law, provided that the manufacturer decides to use this standard and cites it in the product’s declaration of conformity.
The declaration of conformity, its veracity and the actual responsibility for the product to be compliant with the law, with or without the use of EN harmonised standards (or any other standards) remains with the manufacturer. The responsibility to check that the product actually is compliant with the law, with or without the claim of a presumption of conformity, remains with the national market surveillance authorities under the subsidiarity principle.
The presumption of conformity is a facultative facilitation, not a must; it is a beginning of evidence, not a legal assurance that the manufacturer complies with the law.
Fifthly, as pointed out by Mr Schettini, Regulation 1025/2012 does not require any formal ex-ante check by the EC before… the adoption by ESOs of the harmonised standard. Then, the EC can exert its administrative control for the purpose of citation in the OJEU. Even if the Commission does not agree to cite the adopted EN standards in the OJEU, the standard is perfectly usable. To illustrate this, two interesting pieces of information:
1. For more than 40 years the EC’s control prior to citation in the OJEU did not exist at all under the Low Voltage Directive: until 2014, when the LVD was recast-aligned with Decision 768/2008 (NLF), the use of harmonised standards developed under the LVD triggered, from their time of adoption, an opposable presumption of conformity. To my knowledge, over four decades, there were barely any Member States’ safeguard clause procedures raised against these standards.
2. Today, there are disagreements in the application of the European directives on medical devices and gas appliances between the EC services and CEN experts (industry) on the formal presentation of the so-called informative “Annex ZZ” – that describes the correspondence between the standard’s technical specifications and the essential requirements of the EU legislation. As a consequence, a significant number of adopted standards have not been cited in the OJEU. However, manufacturers of medical devices or gas appliances are nevertheless using these standards, because they made a significant investment in contributing to their development and because, as a result, these standards describe the best available technologies that are requested by their customers. And these manufacturers do not complain (too much). Why? Simply because the conformity assessment procedures under these two directives require manufacturers to obtain a certificate (of compliance) from a third party conformity assessment body. Hence, it is no longer the use of the standards that grants them presumption of conformity, but the third-party assessment and the resulting certificate.
To conclude, what matters the most to manufacturers operating on the Single Market is access to the whole territory of the 28 EU Member States in a legally predictable manner. The development and increasing use of harmonised standards under EU New Approach legislation have greatly contributed to this over the past 40 years. I hope that the ECJ will consider this great achievement and preserve a clear differentiation between the legal nature of standards’ specifications as opposed to rules of law in its final ruling.
LLM European Law and Industrial Property Law
29 May 2016
It is due to the Commission’s action that the THSs are adopted. Particularly, the THSs are adopted on the basis of the Commission’s mandate which delegates rule-making power to one of the European standardisation organisation. In addition, the Commission accords the legal effects and grants the presumption of conformity to the THSs by publishing the reference in the official journal. I disagree with the view that Regulation 1025/2012 does not require any ex-ante control. Article 10.5 of that Regulation explicitly states that: ‘…The Commission together with the European standardisation organisations shall assess the compliance of the documents drafted by European standardisation organisation with initial request’. Even more, according to Article 10.6 of the same Regulation: ‘Where a harmonised standard satisfies the requirements which it aims to cover… the Commission shall publish a reference of such harmonised standard…’ This means that prior to publication of the reference, it should be established that the THS satisfies the requirements of the corresponding Union harmonisation legislation. Whether the Commission exercises this prior control or how effective it is, it is another matter.
In my note I explained that Regulation n°1025/2012 does not require any “formal ex-ante check” by the Commission before the publication of a HTS in the Official Journal of the EU”. Indeed, I do not challenge the existence of such control regarding the compliance of the draft THS with the initial request. However the practice shows that such ex-ante check is left either to external independent consultants, or to a “self-assessment” by the Technical Committee that has elaborated the standard, or to the personal evaluation by the concerned Commission Official.
Because of these different informal practices -that are supposedly in line with Regulation 1025/2012, but cannot be really qualified as a “formalized process” of check by the EC, it is be difficult to follow the AG when he argues that… “[t]he Commission exercises significant control over the procedure for the drafting of harmonized technical standards by the CEN”.
When Mr Vahdat, states that “Whether the Commission exercises this prior control or how effective it is, it is another matter” recognizes exactly this point.
Hello, I would like to understand how, if CEN, CENELEC and ETSI are private bodies, they can be subject to Regulation 1025/2012 – or how at least, how that Regulation can be written as if they were so subject. For example, Article 3: ‘… each [ESO] … shall establish its work programme…’ and so on. A BSI paper states that: ‘As with CEN and CENELEC, ETSI is subject to EU Regulation 1025/2012 in relation to its activities as an ESO.’ (http://www.bsigroup.com/LocalFiles/en-GB/EUREF.pdf)
Sorry, I should have added also the matter of the membership being wider than the EEA. I have seen that Albania, in pursuit of CEN/CENELEC full membership, is in the process of transcribing 1025/2012 into national law. Have Turkey, Macedonia and Switzerland done this? But then what about ETSI, with a wider membership still?
Or is it just through 1025/2012 being effective in Belgium (CEN and CENELEC) and France (ETSI), where these organisations are registered? Is that sufficient?
Or – if you will bear with me one more time – is it rather that the EU is not actually imposing obligations on CEN, CENELEC and ETSI? Rather, is it that they are creating requirements that a standards body must fulfil if it is to be considered an ESO?
Then, if such a body agrees to fulfil these conditions, it can be listed in the Annex.
I have a question about this topic. Especially after the CJEU decides that HTS are part of EU Law and that it has the competence to decide over HTS. Does the CJEU decision have any effects on the technical expertise of der ESO and what in general changes now for the work of the ESOs.
Thank you 🙂