What is REACH (Registration, Evaluation, Authorization of Chemicals)?

REACH, is a new European Community Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals. It came into force on 1st June 2007 and replaces a number of European Directives and Regulations with a single system.

Aims

REACH has several aims:

• To provide a high level of protection for human health and environment from the use of chemicals.
• To make the people who place chemicals on the market (manufacturers and importers) responsible for understanding and managing the risks associated with their use.
• To allow the free movement of substances on the EU market.
• To enhance innovation and the competitiveness of the EU chemicals industry.
• To promote the use of alternative methods for the assessment of hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

A major part of REACH is the requirement for manufacturers or importers of substances to register them with a central European Chemicals Agency (ECHA). A registration package will be supported by a standard set of data on that substance. The amount of data required is proportionate to the amount of substance manufactured or supplied.

If you do not register your substances, then the data on them will not be available and as a result, you will no longer be able to manufacture or supply them legally in the EU, i.e. no data, no market!

REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more. Generally, it applies to all individual chemical substances on their own, in preparations or in articles (if the substance is intended to be released from an article during normal and clearly foreseeable conditions of use).
 
Some substances are specifically excluded:

• Radioactive substances
• Substances under customs supervision
• The transport of substances
• Non-isolated byproducts
• Wastes
• Some naturally occurring low-hazard substances
  

Some substances, covered by more specific legislation, have tailored provisions, including:

• Human and veterinary medicines
• Food and foodstuff additives
• Plant protection products and biocides
  

• Isolated byproducts (Byproducts isolated on site)
• Substances used for research and development (Scientific Research and Development)

There are more than 100,000 substances (it was estimated that there were around 30,000 substances before pre-registration) on the European Market in quantities of 1 ton or more per year. Registering all of these at once would be a huge task for both industry and regulators. To overcome this, the registration of those substances already being manufactured or supplied is envisaged to take place in three phases. Registration obligation spread till 2018 in these phases. To benefit from these phased-in deadlines manufacturers or suppliers need to pre-register their substances from 1st June to 1st December 2008 or pre-register later if they meet the appropriate conditions. Pre-registration is not a legal requirement but is strongly advised to make use of the transition period.

Registration

Registration is a requirement for the industry (manufacturers/importers) to collect and collate specified sets of information on the properties of those substances they manufacture or supply at or above 1 ton per year. This information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. This information and its assessment is submitted to the European Chemicals Agency in Helsinki.

The laboratories for the physico chemistry tests that have to be done during registration may be found in the web page of Turkish Accreditation Agency (TÜRKAK) (by entering the test name). Make sure that the laboratory conducts the test accepted within the context of REACH. Be aware that ECHA requires laboratories to be provided with GLP (Good Laboratory Practice) certificates for some tests (example: ecotoxicology, toxicology tests). 

Joint registration and data sharing

This is the principle that for any one substance, a single set of information on its intrinsic properties is produced and that is shared by all those companies manufacture or supply that substance. Business specific (e.g. company name) and business sensitive (e.g. how it is used) information is submitted separately by each company. The Companies will work together to get an agreement on information sharing through a Substance Information Exchange Forum (SIEF). The details of how this information is shared is the responsibility of the businesses involved in the SIEF.
Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.

Evaluation

Dossiers submitted in support of registration will be subject to evaluation under REACH as follows:

• Compliance checking: This is a check of the quality of the information submitted by the industry. It will be undertaken by the European Chemicals Agency (ECHA) in Helsinki and will be on a sample (at least 5%) of dossiers submitted at each tonnage level.
• Dossier Evaluation: For substances registered at the highest tonnage levels (≥100 tons/annum) a proposal is made by the registrant detailing those animal tests they consider are required from the list of standard tests. The ECHA will evaluate these testing proposals to prevent unnecessary animal testing.
• Substance evaluation: This is undertaken by national Competent Authorities on substances that have been prioritized for potential regulatory action because of concerns about their hazardous properties. A key regulatory outcome of evaluation could be the imposition of restrictions on the manufacture, supply or use of a substance. Substance evaluation may also lead to a substance being added to the priority list for authorization or a proposal to change the classification and labeling.

All dossiers will undergo an automated completeness check to ensure that all the relevant pieces of information are present. This completeness check will not assess the quality or suitability of the information.

Authorisation

In order to place on the market or use substances with properties that are deemed to be of “very high concern” industry must apply for an authorization. The European Chemicals Agency (ECHA) in Helsinki will publish an initial list containing substances to be considered for the authorization process by 1 June 2009 (candidate list has been published on 28 October 2008, Article 7 is planned to be placed in Annex XIV as of 14 January). A company wishing to market or use such a substance must submit an application to the ECHA for an authorization. Decisions on authorization are made by the European Commission. Applicants will have 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 must also analyze whether there are safer suitable alternatives or technologies. If there are then they must prepare substitution plans and if not then they should provide information on research and development activities if appropriate.

Restrictions

Any substance that poses a particular threat can be restricted. Restrictions take many forms, for example, from a total ban to not being allowed to supply it to the general public. Restrictions can be applied to any substance, including those that do not require registration. This part of REACH takes over the provisions of the Directive 76/769/EEC.

Classification and labeling
An important part of chemical safety is clear information about any hazardous properties of a substance. The classification of different chemicals according to their characteristics (for example, those that are corrosive, or toxic to fish, etc.) currently follows an established system, which is reflected in REACH. A new EU classification and labeling (CLP) regulation in accordance  with United Nations Globally Harmonized System of Classification and Labeling of Chemicals – GHS  has begun to be applied at the end of  2008. REACH is prepared by taking GHS into account.

Substances of very high concern

Some substances have hazards that have serious consequences, e.g. they cause cancer (carcinogenic), they give rise to genetically modified substances (mutagenic), they have other harmful properties against reproduction of living organisms (reprotoxic) and do not decompose in the environment for a long time (persistent pollutant) and gradually build up in animals (bioaccumulative). These are substances of high concern. This category also includes substances demonstrated to be of equivalent concern, such as “endocrine disruptors”. One of the aims of REACH is to control the use of such substances via authorization and encourage industry to substitute these substances for safer ones.

Information in the supply chain

The passage of information up and down the supply chain is a key feature of REACH. Users should be able to understand what manufacturers and importers know about the dangers involved in using chemicals and how to control risks. REACH provides a framework in which information can be passed both up and down supply chains. 

REACH adopts and builds on the previous system for passing information – the Safety Data Sheet. This should accompany materials down through the supply chain, providing the information users need to ensure chemicals are safely managed. In time these safety data sheets will include information on safe handling and use.

You can reach the laboratory list in Turkey from the web site of Turkish Accreditation Agency (TÜRKAK) for the tests you need at this stage. However you should contact your customer to learn whether they accept the laboratories or the tests to be done.

Source : IMMIB

Ak-kim continues marketing activities of its new product, amine gas.

Ak-Kim, continues the marketing activities of DMEA – one of the raw materials of foundry industry. Amine gas produced by Ak-Kim, used in the process of cold box is approved and confirmed by many users from Turkey and abroad.