European Union: REACH Authorisation & Legal Remedies

Last Updated: 22 April 2014
Article by Claudio Mereu

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:

  1. Carcinogenic, mutagenic or toxic for reproduction (CMR, Category 1A or 1B), as defined in Article 57(a)-(c).

  2. Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), as defined in Article 57(d)-(e), in conjunction with Annex XIII.

  3. 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.

Challenging decisions

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:

  1. 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.

  2. 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.

  3. 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:

  1. 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.

  2. 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.

  3. It infringes Article 58(2) of REACH and the principle of proportionality.

  4. 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.

Conclusions

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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions