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REACH

Position of Unico regarding REACH

REACH

REACH (Registration, Evaluation, Authorisation of Chemicals) is the current system for controlling chemicals in Europe. It became law in the UK on 1st June 2007.For Unico, as a chemical user REACH is intended to provide more information on chemicals and increase confidence in their safe use. In particular, better information on the hazards of chemicals and how to use them safely will be passed down the supply chain by chemical manufacturers and importers through improved Safety Data Sheets. As Unico do not make or import chemicals they have no need to register them.

From 1st December 2008, chemicals that are manufactured or imported into the EU have to be registered with the European Chemical Agency (ECHA) in Helsinki. Registration of chemicals will not be effective immediately. If a manufacturer or importer has pre-registered a chemical they may not have to submit a registration for several years. If a manufacturer or importer has not pre-registered or registered a chemical then it is, in most cases illegal to continue to supply that chemical. Unico has contacted suppliers to obtain assurance that they are complying with the REACH requirements and that the chemicals being used are either pre-registered or registered.

Unico has an obligation to inform the suppliers of chemicals of the intended use of the chemical. This is to allow the supplier to include the use in the registration package. If they do not wish the supplier to know the intended use for commercial reasons then the use must be submitted directly to ECHA by Unico. This may be in the form of a risk assessment package. To conclude: once a chemical has been registered and a safety data sheet submitted for that chemical with the appropriate registration number, Unico have a period of six months to provide ECHA with information of its use if it has not already been registered for that use.

Safety Data Sheets will be changed slightly. Once a chemical is registered the safety data sheet will include the registration number. The data sheets will also include exposure scenarios. An exposure scenario describes the operating conditions and risk management measures that have been identified by the supplier as necessary to use the chemical safely in your process. REACH requires you to follow that advice. If you choose not to then you must justify why the measures you have chosen follow an equivalent or better level of protection for human health and the environment.

Importers- if you directly import anything from outside the EU/EEA, be it a chemical substance , mixture (cosmetics),articles (finished products, e.g. clothes or plastic goods) or articles that contain substances intended for release (e.g. scented bin liner) then you may have responsibilities under REACH.

Companies outside the EU cannot register chemicals themselves but can appoint an EU based agent-i.e. an Only Representative- to act on behalf of their EU based importers.

It is important that if a company is importing, that they are clear what they are importing and in what form. In particular does the product contain any SVHC (Substances of Very High Concern)?

Substances of Very High Concern – these are substances that have hazards with serious consequences e.g. they cause cancer or have other harmful properties and/or remain in the environment for a long time with their amounts in animals gradually building up. A list of these substances the so called candidate list of SVHC’S has been published by the ECHA. This list is up-dated periodically. Any supplier of an article containing a SVHC on the candidate list in a concentration above 0.1% (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. This also applies should a consumer request this information and should be provided free of charge within 45 days of receipt of the request. This duty applies as soon as a substance appears on the candidate list. Therefore suppliers of articles are advised to identify if any of the SVHC ‘s are used in the manufacture of their articles so that they are in a position to provide the required information within the 45 day deadline.

If you produce or import an article you will be required to Notify the ECHA if the article contains an SVHC on the candidate list if both the following conditions are met: the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year and the substance is present in those articles above a concentration of 0.1% weight by weight.

Does the article intentionally release a substance during use e.g. a scented bin liner, air freshener, aerosol?The ECHA guidance document highlights a number of criteria that should be applied to an object to identify whether it is an article with intentional release or a substance or preparation in a container.Generally if the release of substances or preparations from an object is the main function of the object then the object is regarded a substance/preparation in a special container or on a special carrier material and not an article with an intended release of substances.Therefore the intended release of substances from an article normally applies to a secondary function or a specific added quality of the article.The regulation is clear that it is only substances that are intentionally released from articles (under normal or reasonably foreseeable conditions of use) that should be considered for registration.

REACH exemptions:

Radioactive substances within the scope of Council Directive 96/29/Euratom.
Substances subject to customs supervision.
Waste as defined in Directive 2006/12/EC.
Nonisolated Intermediates
Carriage of dangerous substances and dangerous substances in dangerous preparations by rail, road, inland waterway, sea or air.

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