ECHA

Within ECHA, Andreas Herdina heads the Directorate of Cooperation which also holds responsibility for managing the process of drafting and consulting new and updated Guidance documents for publication by the Agency. In this article, he provides his observations on a recurring point of discussion, namely the nature of ECHA's Guidance.

Andreas Herdina, Director of Cooperation

Time and time again, I have seen our partners in implementing the REACH and CLP regulations raise the question of defining the actual nature of ECHA's Guidance. I encountered this during my involvement in the Directors' Contact Group's deliberations on the "Stability of Guidance" when it was suggested that ECHA Guidance should "enter into force" only after a certain "transition period". This idea has also been raised in the context of registrants' duties to update their dossiers "without undue delay", according to Article 22 of the REACH Regulation. However, such notions are at odds with the Agency's understanding of the nature of ECHA's Guidance.

I would therefore like to offer my personal reflections on this recurring subject.

Guidance is designed to provide its readers with advice to help fulfil obligations under REACH and CLP, through further orientation and clarification as well as support to the addressees concerned – industry as well as national authorities. It also publicly communicates how ECHA, the European Commission and Member States' authorities will practically implement the legislation in their operations. Guidance updates incorporate any new interpretation of the law. They also contain a widened range of explanatory examples, accounts of experience gathered and refinements to the scientific regulatory reasoning applied, in short the "stateof- the-art" as recognised at the time of their issuance, and thus a more precise indication of how authorities will and enterprises should proceed in applying the respective norm.

ECHA is obliged to provide explanatory information on the REACH Regulation under its Article 77 (2) (k). Guidance has not only to be useful, but is even necessary, as the entry into force of the REACH and CLP Regulations created important legal obligations for industry. However, at the time, there was no – and there still is only very little – literature explaining these obligations or the processes under REACH and CLP; there was no case law established by the EU Courts or any other Courts interpreting the obligations under REACH and CLP; and there was no regulatory experience in the implementation of REACH and CLP. Consequently, there was (and still is) a great demand for explanations of REACH and CLP and the regulatory system they introduced. Guidance by ECHA, which is available to all interested parties, serves to fill this information gap on the obligations of industry. Without Guidance, every reader would most likely have a different understanding of the REACH and CLP Regulations. As a consequence, every actor would fulfil their obligations differently. This could be detrimental to the purposes of REACH and CLP and certainly would add to the workload of the Agency.

Whilst the purpose of Guidance is therefore clear, what is its nature?

Guidance is solely explanatory in character. It is not a piece of legislation, neither by design nor by default. This is one of the reasons for which ECHA Guidance cannot enter into force. Any underlying legal obligation is already in force since the respective REACH or CLP provision entered took effect (mostly with the main body of REACH in 2007). Thus, Guidance cannot put it into force again, nor can it decree a transition period and thereby delay the application of the law. This is not in ECHA's powers, nor in the nature of Guidance. ECHA is not a law-maker, but an EU regulatory agency.

The second reason that ECHA cannot decree a transition period lies again in the explanatory nature of Guidance. Guidance provides its readers with a deeper understanding and better knowledge of their obligations. Thus, it triggers a cognitive process of realisation in the mind of its reader (just like a book may provide new insights into a subject matter). Evidently, ECHA, as the author of this Guidance, cannot then put this cognitive step in the mind of a third person on hold or into reverse. What the reader has learned, the reader now knows.

It may be in the interest of the reader to act on his newly acquired knowledge or on a different interpretation of the legal text as soon as possible ("without undue delay") or even retroactively, where that is possible. This is the reader's own responsibility. It depends entirely on the individual circumstances of a duty holder under REACH or CLP whether the consequential action can be undertaken immediately (like simply ticking an additional box in the IUCLID file) or whether prolonged work is a necessity (like commissioning additional testing before updating a dossier). In fact, the notion of "undue delay" is a typical "indeterminate" legal expression that leaves the timeline to be determined by the circumstances of the individual case.

A change in the Guidance could thus trigger the need to submit a dossier or to update an existing one.

Apart from the context of evaluation under Title VI of REACH, it is not in ECHA's remit to require the submission of dossiers. It is the responsibility of the duty holder, whilst a competent enforcement authority may, on a case-by-case basis, subsequently assess whether the necessary dossiers have been submitted. The enforcement authority would look at each case individually and may concur with the duty holder or, for instance, reach different conclusions on the period of time which different companies may have to update their dossiers. Therefore, it would be prudent for duty holders finding themselves in such situations, to document the factors that were relevant in deciding on the actions they have taken, for the purpose of a potential need to discuss them with enforcers.

The reader may also disagree with the Guidance and follow his own interpretation of the law. His interpretation may eventually even be upheld by the EU Courts. There is no legal obligation to follow the Guidance as such. However, a diligent businessman can be expected to pay particular attention to issues where he identifies a conflict between his company's policy and ECHA Guidance and may be acting negligently where he does not. Ultimately, it can only be the courts that will establish binding decisions which can settle such matters of disputed interpretation.

My favourite analogy to exemplify the nature of Guidance is to use the example of "maritime guidance" to underpin the arguments put forward above.

Maritime law requires the captain of any ship to navigate responsibly, according to provisions imposing specific legal obligations. To help the mariner, numerous publications are made available, for instance official charts provided by national transport authorities (or, as a world-wide reference, the charts published by the British Admiralty). Additionally, specialised books cover many relevant subjects.

The charts do not create law. They reflect information that is needed for a responsible captain to fulfil the obligations of safe navigation (the location of buoys, traffic separation regimes that have been put into place by respective legal provisions, the depth of the waters, etc.). These charts are explanatory in character. However, they are regularly updated. If a skipper does not follow the latest state-of-the-art information, this might lead to a navigational mistake which again may represent a breach of a legal obligation stemming from the underlying law, but not from the chart as such.

Equally, specialised literature may add to the captain's knowledge.

book may, for instance, describe new test results comparing the qualities of different types of anchor. If the skipper wants to use the best anchor, it may be available for purchase off the shelf. But, there may also be a long delivery time for a particular anchor. Or, it may not fit the design of the boat at all, necessitating the choice of a second-best anchor. Someone navigating in waters with very different anchor grounds may chose the best universal anchor whereas another skipper may fit a particular boat with the anchor best suited for a specific navigation area. Just like in the case of updated or new ECHA Guidance, once the skipper (reader) has acquired additional knowledge from the new book, action to fulfil a legal obligation may need to be taken according to the circumstances.

Ultimately, however, it will again be up to European Courts to find a more binding interpretation of the nature of Guidance. For the current lack of it, these thoughts are the best I can offer at this juncture.