UK: REACH – Issues Emerging In The First Month Of Pre-Registration

Last Updated: 11 July 2008
Article by Paul Sheridan, Valentina Keys and Kate Warnock-Smith

The pre-registration of chemicals under Regulation (EC) No 1907/2006 ("REACH") started on 1 June 2008. By 13 June 2008, the European Chemicals Agency (ECHA) had received pre-registrations from 1,427 companies and had created 7,360 pre-registrations. So far, the pre-registration process has highlighted two issues which are being addressed by ECHA: (1) errors in the submission of data in pre-registration dossiers by companies, and (2) identification of substances which may be classified as substances of very high concern (SVHC).

To view the article in full, please see below:

Full Article

The pre-registration of chemicals under Regulation (EC) No 1907/2006 ("REACH") started on 1 June 2008.  By 13 June 2008, the European Chemicals Agency (ECHA) had received pre-registrations from 1,427 companies and had created 7,360 pre-registrations.  So far, the pre-registration process has highlighted two issues which are being addressed by ECHA: (1) errors in the submission of data in pre-registration dossiers by companies, and (2) identification of substances which may be classified as substances of very high concern (SVHC).

New Guidelines For Submission Of Pre-Registration Dossiers

Pre-registration for single chemicals is available on-line via the REACH-IT portal.  According to ECHA, for 2% of these REACH-IT pre-registrations, chemical identity information was not provided in line with ECHA guidelines. 

The option to bulk pre-register more than one chemical at a time is not yet available on the REACH-IT portal and companies must therefore use a temporary manual registration procedure.  Apparently, many of the dossiers submitted via the temporary submission procedure could not be processed due to inadequate or incomplete information.  In response to this, ECHA has published two new guidance documents to assist companies in preparing and submitting dossiers for pre-registering their chemicals: Data Submission Manual 4: How to submit a valid dossier to ECHA and complete the dossier and Data Submission Manual 5: How to complete a Technical Dossier for Registration and PPORD Notifications.  ECHA hopes that by using these manuals, companies will have more certainty that their dossiers pass the completeness check at the first submission. 

Pre-registration (which has the advantage of giving companies extended registration deadlines) ends on 30 November 2008. Companies should therefore take full advantage of the time available to them to ensure registration dossiers are complete and contain all the correct information, as incomplete pre-registration dossiers will not be accepted by ECHA. 

Substances With Properties Of Very High Concern (SVHCs)

On 30 June 2008, ECHA began a public consultation on the first draft list of substances that could become subject to stringent authorisation requirements prohibiting marketing and use unless manufacturers and importers can show there is a compelling reason to allow their manufacture. Each entry on the "candidate list" of SVHCs has been suggested by the Government of an EU Member State.

SVHCs are defined in Article 57 of REACH and include substances which are:

  • Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC,

  • Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or

  • Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)

The 16 substances on the candidate list are anthracene, 4,4'-diaminodiphenylmethane, dibutyl phthalate (DBP), cyclododecane, cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide sodium dichromate, musk xylene, DEHP, Hexabromocyclododecane (HBCDD), short chain chlorinated paraffins (SCCPs), bis(tributyltin)oxide, lead hydrogen arsenate, triethyl arsenate and benzyl butyl phthalate (BBP).

The strict authorisation requirements oblige those manufacturers, importers or suppliers using or making available a substance in the SVHC candidate list to apply for an authorisation for each use of the substance within the deadlines set and to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants would also need to analyse whether there are safer suitable alternative substances or technologies. If there are, they must prepare substitution plans, if not they should provide information on research and development activities. The European Commission may amend or withdraw any authorisation on review if suitable substitutes become available.

In respect of the 16 substances, stakeholders are invited to submit scientific commentary on the identification of the substances as SVHCs as well as further information relating to the use and exposure of the substances and safer alternative substances and techniques. The commentary and information should be submitted by 14 August 2008. Following stakeholder input, a committee of EU Member State experts convened by ECHA will vote on the list. ECHA hopes to publish a final list in October 2008. This list will be created as an annex to REACH (Annex XIV) which covers substances that are subject to authorisation requirements. It is anticipated that the list will gradually increase as more information becomes available on other substances under the REACH registration process.

To access the consultation and instructions on how to make submissions to the consultation, click here.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 10/07/2008.

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

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

In association with
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.