Simon Robinson of specialist chemical software consultancy Safeware Quasar summarises the REACH legislation and the impact it is likely to have.
First introduced in June 2007 the REACH legislation is one of the most radical changes to ever hit the chemical sector. REACH is designed to overhaul the current system of registration of chemicals across the EU and create a single database for the inclusion of all chemicals in the European industry. It will also have a knock-on effect, with manufacturers that use chemicals in their production processes being affected.
REACH stands for Registration, Evaluation and Authorisation of Chemicals. Registration will require companies to register information on chemicals they use, including properties, uses and safe ways of handling them, to a newly created EU Chemicals Agency. Producers and Importers need to pass information to ‘downstream users’ – these are the aforementioned manufacturers that use chemicals in their production process. One of the primary concerns of the legislation is that chemicals can be used without creating risks for users and the environment.
Evaluation involves public authorities looking at the registration dossiers in extensive detail. It is at this stage animal testing proposals are considered. REACH sets out to limit animal testing to an absolute minimum, making data sharing on results compulsory, and ensuring alternatives are used wherever possible.
For Authorisation, companies need to show an adequate level of control of the risks associated with the most harmful chemicals. These are the substances that cause cancer, mutations or reproductive problems, accumulating in the human body or in the environment. The socio-economic benefits must outweigh the risks of these chemicals, with no suitable alternatives available.
The first phase of registration is due between 2008 and 2010. This involves the registration of high risk substances as well as substances supplied in quantities of 1,000 tonnes or more.
By 2013 it is aimed that the second phase will be completed. This will be applicable to substances supplied in quantities of 100 tonnes or more. This will be 6 years after the regulations came into force, and just over half way through the 11 year period of implementation.
By 2018 the final phase of the registration should have come into force, with the new rules applicable to substances supplied in quantities of 1 tonne or more.
Not just producers, but also users…………
The EU's chemical industry produces 31 per cent of the world's chemicals. However it is not only chemical manufacturers who need to be aware but also the millions of others who work in industries that use chemicals in their production processes. The legislation may also require users of chemical substances to provide information on their specific uses and the safety procedures associated with that use.
Although the chemical industry is highly regulated, it has been clear for many years that the pre-REACH regime for dealing with chemicals to assess their safety was not working as efficiently as it might. The system differentiates between “existing substances” i.e. all chemicals declared to be on the market in September 1981, and new substances i.e. those placed on the market since that date.
New substances are currently tested and assessed for possible risks to human health and the environment before they are marketed in volumes starting at 10 kg. In contrast, pre-existing substances amount to more than 99 per cent of the total volume of all substances on the market which are not (and have not been) subject to the same testing requirements.
REACH was introduced with the intention of creating one database for entry of all chemicals used in the EU, with the onus on a business to show that the chemicals it uses are safe.
It is also intended to encourage the replacement of hazardous chemicals with safer ones and to spur the chemicals sector into researching and developing safer alternatives. Employers say it will impose heavy costs and cause firms to flee Europe. The European Commission, original author of REACH, forecasts it will cost the chemical industry 2.3 billion euros over 11 years. Total costs to industry are estimated between 2.8 billion and 5.2 billion euros. However many believe that there will not be a problem for small businesses and that better chemical regulation will actually create new markets for safer chemicals. Starting the process…..
The first step in REACH compliance is to establish how your business operates within the REACH framework. This helps to identify roles, legal obligation and potential areas of risk. Another key area to look at is the levels of communication up and down the supply chain. Ensure REACH compliance is a clear objective of your suppliers and customers, and likewise that they receive a clear message that it is on your agenda. Using a module like REACH+ from Safeware can remove a large amount of the potential headache caused by complexities of the REACH legislation.
A major aspect of the new legislation is the total dependence on IT to ensure its success. This is a daunting prospect for the entire industry, and those affiliated with it. However, the lengthy implementation time coupled with manufacturers, importers and downstream users ensuring they are adequately prepared will almost certainly lead to a safer chemical industry for people, animals and the environment.
One area of the regulations that is frequently overlooked by industries on the periphery of the chemical industry, is that the REACH regulations also applies to finished articles, such as Motor Vehicles, Computers, Printers, Industrial Machinery and the ancillary spare parts that accompany these type of products.
REACH establishes a mechanism for identifying Substances of Very High Concern (SVHCs), a list that is published on the European Chemicals Agency (ECHA) web site. http://echa.europa.eu/chem_data_en.asp The list, known as the “Candidate List” is the source for the eventual authorised substance list (Annex XIV)
The first “candidate list” will officially be published in October, and will immediately trigger the obligation of Article 33 of REACH – Suppliers of articles (Producers, Importers and distributors) containing a substance on the “Candidate List” at a concentration > 0.1 %w/w are required to provide the recipient with information to enable safe use of the article – as a minimum the name of these substances. Within the consumer market retailers must provide such information to the consumer within 45 days of such a request.
The nature of a final article made from multiple components from multiple suppliers, it is clear to see the impacts of Article 33 when dealing with complex supply chains.
Suppliers of articles are advised to monitor each revision and publication of the candidate list and advise suppliers that they should inform them immediately of their presence above 0.1 %. Many suppliers are taking a proactive approach and publishing REACH policies on their web site and building checks into their Standard Operating Procedures to ensure customers are aware of the candidate list and that they are updated when such information is available. - The message is quite clear that in an ideal world these should be removed from the article.
The inclusion of Articles in REACH was a long debated process, and indeed some of the interpretations are still in discussions with some Member states. There is now a high level of transparency required in the industry because of this inclusion of Article 33. The complexity of some articles and their respective supply chains make this an almost impossible task, however companies will have to ensure that procedures are in place to ensure their products are safe, and that information is communicated down the supply chain as soon as it becomes available.
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