ECHA

On 1 June 2011, all EEA produc­ers and importers of articles will have to notify ECHA about any Substances of Very High Concern (SVHC) on the EU Can­didate List* if both of the following con­ditions are met:

• the substance is present in arti­cles produced and/or imported above a concentration of 0.1% (weight by weight)
• the total amount of the sub­stance present in all articles exceeds 1 tonne per producer/importer annually.

To support producers and importers of articles in complying with their legal requirements, ECHA has made available web pages on this specific issue. These pages include questions and answers and a data submission manual contain­ing practical advice on how to carry out a notification. An updated version of the Guidance on requirements for sub­stances in articles was published on the ECHA website on 1 April.

Establishing SVHC presence

There are different ways in which pro­ducers and importers can find out whether a substance included in the Candidate List is present in their article. In general, they receive this information from actors in their supply chain, so fur­ther chemical analysis of the article may not be the first thing to consider. When in doubt, Chapter 5 of the Guidance on requirements for substances in articles can be consulted for more information. Other important information that needs to be included in the notification dossier includes for instance the type of the article and the function of the sub­stance in the article. Once producers and importers have established that their article contains a substance included in the Candidate List, the next issue they need to address is the level of its concentration in the article. To determine whether the threshold of 0.1% has been reached, the concentra­tion of the substance in the article needs to be calculated. If the article has several different components, the concentration should be calculated in relation to the article as produced or imported. This means that if a car is imported, the con­centration in the whole car can be calcu­lated. If a hubcap for a car is imported, it is the concentration in the hubcap that should be calculated**.Section 4.4 of the REACH guidance on requirements for substances in ar­ticles provides further explanation and some examples on how to proceed.

* Candidate List of Substances of Very High Concern for Authorisation

** See Guidance on requirements for substances in articles

Exemptions in two cases

Companies are exempted from notify­ing ECHA in two cases. The first case is when they can exclude the exposure of humans or the environment to the SVHC in the article during normal or reasonably foreseeable conditions of use, including disposal. However, pro­ducers and importers should be aware that it may be more difficult and costly for them to demonstrate "no exposure" rather than proceeding with their noti­fication. The second case is when the sub­stance is already registered for the in­dicated use. Section 6.4 of the Guid­ance on requirements for substances in articles provides some advice on how to find out if the substance is already registered for that use. If it is not certain that a specific use of the relevant SVHC is already registered, companies are ad­vised to notify.

When to notify?

The notification of substances in articles should be made at the latest 6 months after the substance has been included on the Candidate List. The obligation how­ever only starts to apply from 1 June 2011. This means that for substances included in the Candidate List before 1 December 2010, notifications have to be submitted not later than 1 June 2011. For substances included in the Candidate List after 1 December 2010, notifications have to be submitted no later than 6 months after the inclusion of the substance. Producers and importers are advised to update the notification if the infor­mation they have included has under­gone changes. Examples of such chang­es could be: change in tonnage range, production/import of different articles (with e.g. different use) containing the same SVHC etc. If the production/import ended be­fore the obligation to notify enters into force (i.e. 1 June 2011 for substances placed on the Candidate List before 1 December 2010 or 6 months after a sub­stance has been included in the Candi­date List) then producers and importers do not need to notify. The information submitted in the notifications will add to a better un­derstanding of how Substances of Very High Concern are used in articles in the EU.

Further information

• Web page on substances in articles, in­cluding Q&A
• Data Submission Manual: How to pre­pare and submit a Substance in Articles Notification using IUCLID
• Guidance on requirements for substanc­es in articles
• Candidate List of Substances of Very High Concern for authorisation
• Article 7 of the REACH regulation
• To determine your general obligations under the REACH Regulation and how to fulfil them, you can use the Naviga­tor.

How to prepare and submit a notification   To start a notification, producers and importers should use the IUCLID soft­ware available free of charge on ECHA's IUCLID 5 web page. The Data Submission Manual for "How to prepare and submit a Substance in Articles notification" pro­vides assistance on how to proceed with the notification. Datasets for all substances on the Candidate List can be found on the ECHA website. The datasets contain the iden­tity (substance name, EC and/or CAS number), composition and the classifi­cation and labelling of the substance. After downloading the dataset for the substance whose presence in articles producers and importers need to notify, the datasets are imported into IUCLID 5.The notification can then be com­pleted by adding the company's iden­tity and contact details, the registration number if available, the tonnage range of the substance, a brief description of the uses of the substance in the article itself (technical function) and the uses of the article (e.g. industrial, consumer or professional use, indoor/outdoor use, high/low release).   The description of use can include information on how the ar­ticle is foreseen to be handled (e.g. in contact with skin), how it is likely to be disposed of and in which part of the article the SVHC is present (for complex articles made of various parts).Once the Substance in Articles notifi­cation dossier has been created, produc­ers and importers are advised to use the Technical Completeness Check (TCC) tool. This IUCLID 5 plugin will detect any missing information in the dos­sier before the dossier is submitted to ECHA. The latest version of the TCC plug-in can be downloaded from the IUCLID 5 web page (http://iuclid.echa.europa.eu/).    The notification should then be submitted to ECHA via REACH-IT.