The chemicals deadlines: REACH places the responsibility on industry to manage the risks that chemicals can pose to human health and the environment. The REACH registration deadline is 30 November 2010. Companies have also to notify by 1 January 2011 the classification and labelling of the substances they place on the market to the European Chemicals Agency (ECHA), who will publish the information in the Classification & Labelling Inventory.
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1. REACH Registration is needed to manage the risks that chemicals can pose
Registration is one of the key elements of REACH, which places the responsibility on industry to manage the risks that chemicals can pose to the human health and the environment. Companies must document how to control such risks by sending a registration dossier to the European Chemicals Agency, ECHA.
To prepare the dossier, companies must first gather data about the environment and health properties of their chemical. Companies need to share such data with other companies producing or importing the same substance, in so-called Substance information Exchange Fora (SIEFs).
The dossier consists of a common part which is prepared and submitted together with other manufacturers or importers of the same substance, and an individual part which contains information that is specific to the company. The common part is submitted by the so-called Lead Registrant, nominated in agreement with the other members of the SIEF.
The registration dossiers are submitted electronically via the REACH-IT tool.
The deadline for registration is 30 November 2010
The deadline is 30 November 2010 for:
* substances produced or imported in volumes of 1000 tonnes per year or more
* substances that are carcinogenic, mutagenic or toxic to reproduction and produced or imported in volumes of 1 tonne per year or more
* substances that are very toxic to the aquatic environment and produced or imported in volumes of 100 tonnes per year or more
For other substances, the deadlines for registration are 2013 and 2018.
Registration, more information
Importers and producers of chemicals need to register
REACH affects companies that import or produce chemicals. This has to be understood in the broad sense, and such companies do not necessarily belong to the chemicals sector as commonly understood, e.g. metals are included.
Users of chemicals, in principle in all industry sectors, may also be affected, in two ways. First, they depend on the availability of substances on the market and thus on the latter to be registered (non-registered substances manufactured or placed on the market after the deadline are illegal). Secondly, the registration process will generate manufacturers and importers recommendations for safe use of substances. These recommendations will be passed on in the supply chain. Users of chemicals will need to follow these recommendations, or, in certain cases, make their own risk assessments for their specific uses.
Authorisation under REACH is necessary to control the risks linked to high risk substances and to progressively replace such substances
The authorisation system of REACH aims to ensure that the risks from substances of very high concern are properly controlled, and to progressively replace these substances where there are suitable alternatives. If there are no such alternatives the use of the substance may be authorised if it is shown that socio-economic benefits outweigh the risk to human health or the environment. An authorisation will also be granted if the risk from the use of a substance is adequately controlled, i.e. the exposure levels are below a safe threshold.
In practice, companies will need to have an authorisation from the European Commission if they want to produce or use a substance that is subject to the authorisation system.
REACH made easier
REACH has been a priority for Vice-President Tajani and Commissioner Potoc(nik since they took up their mandate early 2010. They visited ECHA soon after this and lifted deadlocks that undermined the correct functioning of the authorisation process. They also agreed on a roadmap for identification of substances of very high concern and agreed on criteria to identify substances that are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative.
In collaboration with ECHA, the Commission has also run information campaigns to raise awareness about REACH. ECHA has published extensive guidance to help companies understand their obligations and comply with them, and specific effort has been made in the past few months to make them available in 22 of the EU languages. The Commission will publish the upcoming guidance on authorisation in all Community languages.
Regarding registration, in the beginning of this year the Commission set up a so-called “Directors Contact Group”, comprising director-level representatives of the Commission, ECHA and 6 industry associations, representing SMEs and most companies having to register chemicals by this first deadline. The Group has monitored industry’s preparedness to register by this deadline, identified priority issues of concern in meeting obligations and regarding a secured supply of high-volume substances to downstream users, and worked on practical solutions to these issues. They have established solutions to the majority of the issues identified.
Companies and especially SMEs are also supported by helpdesks dedicated to REACH and CLP and operating at ECHA and in all Member States. Vice-President Tajani has addressed them to underline the importance of their task and of their adequate staffing in view of the peak workload they can expect as the deadline approaches. The Commission has also called on Member States to step up efforts to help companies pass this milestone with success.
2. Classification and Labelling of substances must be notified under CLP to establish an inventory
Companies have to notify the classification and labelling of the substances they place on the market to the European Chemicals Agency (ECHA), who will publish the information in the so called Classification & Labelling Inventory. The purpose is to make the information about the hazards of substances available to all stakeholders and to allow all companies placing the same substances on the market to come to an agreed classification. This is important to make sure that information about all hazards are appropriately communicated to all users of substances and that equal protection levels are ensured.
The obligation to classify and label any substance placed on the market has existed in accordance with the Dangerous Substances Directive (Directive 67/548/EEC). To prepare the notifications, companies must, on the basis of the available data, classify them in accordance with the criteria contained in the CLP Regulation (which implements in the EU the UN Globally Harmonised System (GHS). CLP stands for Regulation on Classification, Labeling and Packaging.
The information to be submitted in notifications is limited and ECHA has provided several IT tools that can be used for submission of the notifications.
The deadline for notification is 1 January 2011
The deadline is 1 January 2011 (in practice Monday 3 January 2011) for all substances placed on the market before or on 1 December 2010. Notifications for substances that are placed on the market only at a later date (e.g. newly developed substances) have to be submitted within 1 month after their placing on the market.
Notification by importers and manufacturers only for substances that were not registered under REACH
All substances subject to registration under REACH as well as all hazardous substances when they are placed on the market by themselves or in mixtures above the concentration limits that result in the classification of the mixture must be notified. However, for substances that have been registered under REACH already before the notification deadline, there is no need for the registrants to submit a notification as ECHA can extract the relevant information for the C&L Inventory from the registration dossiers.
Manufacturers or importers can submit notifications individually or if there are several that place the same substances on the market they can submit the notifications as a group. CLP does not require joint notifications, unlike REACH.
Given that there are no tonnage limits for submitting notifications which is different from the registration obligations under REACH many more companies will be affected by the notification of the classification and labelling, including in particular SME’s.
Notification of classification and labelling made easier
The Commission and ECHA have run information campaigns to raise awareness about CLP. ECHA has published extensive guidance to help companies understand their obligations and comply with them.
ECHA has developed a range of different IT tools to facilitate submission of the notifications (IUCLID 5 CLP notification template, Excel tool for preparation of bulk submissions, online creation in REACH-IT). Companies can choose the tool that is best suited for their circumstances.
Companies and especially SMEs are also supported by helpdesks dedicated to REACH and CLP and operating at ECHA and in all Member States. Vice-President Tajani has addressed them to underline the importance of their task and of their adequate staffing in view of the peak workload they can expect as the deadline approaches. The Commission has also called on Member States to step up efforts to help companies pass this milestone with success.
Chemicals - CLP/GHS - Classification, labelling and packaging of substances and mixtures
Source: European Commission
