EU Regulatory Bulletin contents
- BPR amendments have been published in the EU Official Journal
- REACH authorisation & legal remedies
- EU Commission to propose rules on REACH data sharing
- ECHA's Board of Appeal decides on substance ID case
Partner Claudio Mereu has published an article in the April edition of ''Speciality Chemicals Magazine'', where he discusses two ongoing legal cases that could affect the REACH authorisation process.
The authorisation procedure under the REACH regulation aims to assure that the risks from Substances of Very High Concern (SVHCs) are properly controlled and that these substances are progressively replaced by appropriate alternatives while ensuring the good functioning of the EU internal market. In this regard, EU manufactures and importers bear risks and responsibilities along the process. At the same time, challenging authorisation decisions is also another important possibility that must considered by companies. As an example, the ongoing SVHC cases of two anhydrides (hexahydrophthalic anhydride (HHPA) and methylhexahydrophthalicanhydride (MHHPA)) and chromium trioxide are discussed further below.
A stepwise process
Authorisation under REACH is a pretty straightforward process. The first step consists of the identification of a substance as an SVHC and its inclusion in the Candidate List. The identification assessment is performed in accordance with Article 57. Three groups of substances can be identified as SVHCs, which meet the criteria for classification as:
Carcinogenic, mutagenic or toxic for reproduction (CMR, Category 1A or 1B), as defined in Article 57(a)-(c).
Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), as defined in Article 57(d)-(e), in conjunction with Annex XIII.
Having an equivalent level of concern to the first and second categories, e.g. endocrine disruptors as per Article 57(f). These can be identified on a case-by-case basis.
The identification is laid down in a proposal prepared by a Member States (MSs) or by the European Chemicals Agency (ECHA), under instructions from the European Commission (EC), in the form of an Annex XV dossier which is submitted to ECHA. Next, within a specified deadline, there is a public consultation period, during which interested parties may submit comments. 60 days from the date of circulation, the other MSs or ECHA may also comment on the identification of the substance.
Going on the SVHC list is the first step towards authorisation procedures
Then, within 15 days of the end of the 60-day period, EVHA must refer the dossier to the Member State Committee (MSC), provided that comments had been submitted to the dossier. Finally, if within 30 days of the referral, the MSC reaches a unanimous agreement on the identification, ECHA is obliged to include the substance on the Candidate List. If unanimity is not reached, the decision goes to the EC and MSs, under the so-called ‘comitology procedure’.
European producers and importers whose substances are on the Candidate List have certain responsibilities. In particular, they must update their Safety Data Sheet (SDSs) with new information. On the other hand, those manufacturing or importing an article must inform customers about the presence of an SVHC and provide an SDS and advice on safe use.
Moreover, the relevant market players need to notify ECHA if an SVHC is present in the article at a concentration above 0.1% w/w and exposure cannot be excluded. The major consequence for a substance being included on the Candidate List is that it produces a ‘blacklist effect’, which sends a signal to customers and competitors. If final authorisation is not granted, the substance must be withdrawn from the market.
Periodically, ECHA looks at the substances on the Candidate List and identifies and recommends priority substances to add to Annex XIV, which leads us to the second step in the authorisation procedure: prioritisation. Usually, priority is given to substances with PBT or vPvB properties, wide dispersive use or high volumes.
ECHA send its recommendation to the EC but, prior to that, it must allow interested parties to submit comments within three months of the date of publication. In addition, the MSC prepares an opinion on the draft recommendation taking into account the comments received. Finally, before completing its recommendation, ECHA considers the position of the MSC, as well as the comments received during the public consultation.
The final stage of the process is the inclusion of candidate substances in an Annex XIV Authorisation List. Based on the recommendation of ECHA, the EC prepares a draft amendment of Annex XIV. This proposal includes transitional arrangements, i.e. the sunset date and date for submitting applications for authorisation, which must be at least 18 months before the sunset date.
HHPA (left) and MHHPA (right) have been classified as ‘respiratory sanitisers’ under the CLP
At the end, the EC adopts a final decision under the comitology procedure, which is then published in the Official Journal as an amendment to Annex XIV. From this moment, the SVHC becomes subject to authorisation. These substances cannot be placed on the market or used after a given date, unless an authorisation is granted for a specific use or the use is exempted from authorisation.
If the relevant EU producer or importer is negatively affected by an SVCH or candidate listing decision adopted by ECHA or the EC, litigation before the EU General Court could be a next step. To that end, from substantive point of view, there are three measures subject to legal challenge: an inclusion in the Candidate List (an ECHA decision), an inclusion in Annex XIV or a denial of authorisation (both EC decisions).
An item of ongoing litigation concerns the inclusion in the Candidate List of two anhydrides (Case T-134/13 - HHPA and Case T-135/13 - MHHPA) on the grounds of Article 57(f) of REACH. These substances have been classified as ‘respiratory sanitisers’ under the Classification, Labelling & Packaging Regulation. In essence, the arguments submitted by the applicants are threefold:
Respiratory sensitisers are not SVHCs and ECHA did not provide sufficient evidence that HHPA is of equivalent concern in the absence of irreversible effects, consumer and worker exposure or recent and updated data to support its assessment, which was based on a scientifically questionable read-across approach.
The lack of objective criteria to determine whether a substance is an SVHC and the fact that ECHA did not take into account all of the information available or provided by the industry violates the rights of defence.
Choosing to add HHPA to the Candidate List, rather than taking another regulatory measure, is disproportionate.
It is important to point out that this is a first case of its kind and may have important implications as it will define the legal test for placing respiratory sensitisers on the SVHC List.
Suppliers of chromium trioxide argue that it should be exempt from authorisation in chromium plating.
A second interesting ongoing case (T-360/13) before the EU General Court refers to the EC’s inclusion of chromium trioxide as a CMR substance in Annex XIV. The Annex XV dossier was prepared by Germany. In essence, the applicants (Vecco et al.) have argued that the EC decision placing chromium trioxide in Annex XIV without providing for an exemption for the galvanising industry use is unlawful because:
It is based on a number of manifest errors of appraisal and it does not contain an exemption from authorisation in respect of the use of chromium trioxide in the chromium plating industry, which meets the requirements for exemption of Article 58(2) REACH.
It is based on an underlying assessment of occupational risk related to the use of chromium trioxide in chromium plating that is scientifically and legally flawed.
It infringes Article 58(2) of REACH and the principle of proportionality.
The applicants were not granted access to key documents that formed the basis of the EC’s decision, and therefore their rights of defence were violated.
This case is also a first of its kind and will have wide implications for the industry as it will establish the legal test for exempting substances from authorisation requirements under Article 58(2). Importantly, one of the questions at stake is whether the existence of separate EU legislation on worker protection, with concrete measures taken by MSs to protect workers from exposure to carcinogens at work, satisfies the test of Article 58(2) for granting an exemption to a specific use or category of use of a substance.
Decisions on the inclusion of substances in the Candidate List and ultimately in the Authorisation List have a tremendous impact on the marketplace, not only because they constitute new regulatory constrains for those who are subject to it, but also because they create an undeniable ‘blacklist effect’.
On 9 December 2013, the EC adopted a document aimed at implementing the SVHC Roadmap to 2020. The SVHC Roadmap seeks to constitute an alternative to inclusion in the SVHC list and focuses on how to identify new substances of concern and analyse the risk management options (RMOs) that may be appropriate to the particular substance of concern. The implementation plan also provides an outline of how progress monitoring and communication towards stakeholders and the general public is envisaged.
These efforts are certainly positive although they will not assist those whose substances have already been included in the Candidate and/or Authorisation Lists. It remains to be seen how the new RMOs will be implemented in practice. Meanwhile, the ongoing court cases will constitute valuable guidance regarding the EC’s and ECHA’s actions.
Sign up to our email digest