Described as one of the most complex pieces of legislation to ever come out of Europe, the Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals or more commonly known as REACH, entered into force on June 1st 2007. The Regulation will drive major changes in the global chemicals industry most significantly, for manufacturers and importers of substances and preparations into the EU. However, considerable implications will also exist for companies that either use or process chemicals to manufacture products in the EU such as the textile, electronic or automobile sectors. Also affected by the REACH Regulation are manufacturers and importers of products that are designed to emit chemicals such as printer cartridges, pens, fade-out jeans, adhesive tape etc, as well as products which have an unintentional release of chemicals due to their properties such as furniture and clothing.

The REACH Regulation, which implements the EUs New Chemicals Policy will replace at least four major pieces of existing EU legislation controlling chemicals, with a single uniform system that will make chemical Manufacturers and Importers responsible for Registering substances manufactured or imported into EU Member States in volumes greater than 1 tonne per manufacturer/importer per year. Registration timelines have been prioritised according to volume and hazard and will be phased in over time. The first substances to undergo Registration by the deadline of December 2010, will be substances imported or manufactured in volumes greater than 1,000 tonnes or more per year and substances of very high concern such as: mutagens, carcinogens and reproductive toxins (CMR substances). The second registration deadline of June 2013 will capture substances in the volume bracket of 100-1000 tonnes per year. Finally, substances placed on the market in volumes greater than 1 tonne per year will need to be registered by June 2018. Failure to register a substance with the newly established European Chemicals Agency (ECHA) based in Helsinki will make it unlawful to manufacture or import a substance into the European Union.

REACH Terminology

The REACH regulation uses some terminology that although not complex, is important to get to know early on. A Substance is in effect a single chemical. A Preparation is a mixture of chemicals. An Article is an object that has a defined shape which determines its function to a greater degree than does its chemical composition. Plastic chips therefore are regarded as substances or preparations but when manufactured into fibre becomes an article. Fibre, fabric and apparel are all therefore Articles.

Pre-Registration

As a first requirement for manufacturers and importers of chemicals, careful consideration should be given to Pre-Registering substances during the Pre-Registration window, which extends from June 1 2008 to December 1 2008. The Pre-Registration process is straightforward compared to full Registration, and will require the submission of a limited amount of information such as contact details and estimated tonnage band. Pre-Registration is designed to enable the authorities to calculate the number and volumes of chemicals on the market and to ease the formation of Substance In formation Exchange For a (SIEFs) whereby, manufacturers and importers will be able to work together to compile the necessary information and to share the costs to fully register chemicals. Failure, to Pre-Register chemicals will exclude manufacturers and importers from taking advantage of the phase in arrangements, forcing Registration to begin from June 2008. The pre-registration deadline therefore is an important deadline and one not to miss!

Registration

During the Registration process, EU manufacturers and importers of chemicals will have to compile and submit Registration Dossier that should prove they are managing their chemicals safely. This will involve generating and assessing hazard data on the physiochemical, toxicological and eco-toxicological properties of a substance. For substances manufactured or imported in volumes greater than 10 tonnes/year, a Chemical Safety Report (CSR) will also have to be submitted to the European Chemicals Agency. In addition to reporting the hazard data associated with a substance, the intended uses along with the associated risks and proposed risk management measures in the form of exposure scenarios for each intended application of the substance will also have to be detailed. These exposure scenarios will eventually be communicated to the down stream users of the substance as annexes in Safety Data Sheets.

Only Representatives

Companies based outside the European Union also have the option to Register substances imported into Europe in quantities over one tonne per year by appointing an Only Representative to act on their behalf. In this scenario the EU importers then in effect become downstream users of the substance in question and will not have to perform the expensive registration themselves. Despite the costs and resources involved, registering a substance using an only representative will ensure that non-EU manufacturers can continue to export freely to the EU and will prevent their individual EU customers having to Register the substance independently. Companies manufacturing dyes and other textile chemicals that are exported to Europe should seriously consider this option.

Articles and Fade-out Jeans

Registration requirements also exist where a substance in an article (i.e. very simplistically, a manufactured product) is designed to be emitted during normal and foreseeable conditions of use, for example, a pen or printer cartridge. Current REACH guidance also stipulates that the dye in fade-out jeans is seen as being intended to be released and therefore requires Registration. Lets take for instance a company that imports fade-out jeans into the EU. If that dye was present in quantities of greater than 1 tonne per year per importer then that importer would need to Register that dye, if that dye has not already been registered for that use. Manufacturers of articles should now be determining if chemicals in their products are designed for release under normal foreseeable conditions.

Sizes on textiles imported into Europe

All is not straightforward however. What happens when companies import fibre or fabric into Europe that contain sizes and other processing chemicals? Many would argue that sizes are added to fibre which are then intended to be released under normal or reasonable foreseeable conditions of use as the legislation words it. The current draft guidance documents however appear to be rather unclear on how such chemicals will be tackled. The matter is further complicated by the fact that sizes are often polymers that are presently excluded from REACH but the monomers used to manufacture polymers do need to have been registered. The message here is watch this space.

Articles containing substances of very high concern

Another part of the REACH Regulation addresses articles containing substances of very high concern. These are substances such as carcinogens, mutagens and reproductive toxins and substances that are persistent, bio accumulative and toxic in the environment. One could imagine some textile chemicals such as flame retardant finishes that may fall into the later category. In this instance, there will be a requirement to notify the authorities if articles such as textile products are being imported into Europe containing such chemicals in quantities totalling over 1 tonne per year, present in concentrations greater than 0.1% and have not already been registered for that use. The authorities may in turn then request that such substances are registered.

Preparation for REACH

To ensure continued access to the European market it is critical that chemical manufacturers start to look at their REACH obligations and the options open to them. Downstream users of chemicals also need to ensure that their use of a substance is registered by Manufacturers/Importers. Whilst, it is probably still too early to begin approaching suppliers to enquire about their Registration plans, early preparation is essential. As a first step, downstream users should now be reviewing their product portfolios, identifying their suppliers per product and the quantities purchased and determining their own position in the supply chain Manufacturer/Importer/ Downstream User. In the years ahead, downstream users should be aware that they will eventually be called upon by their suppliers to provide use and exposure information and to comment on risk management measures as well as passing any new hazard information to their supplier.

Evaluation

Once the Registration Dossiers have been received by the authorities they will be evaluated for completeness. A more detailed evaluation will be undertaken by the Competent Authorities in Member States countries, which may result in a request for further testing.

Authorisation

For substances of very high concern Authorisation will be required before use. Industry will be able to continue to manufacture and use such chemicals if the risks can be adequately controlled or there is a strong socio-economic argument for doing so. Such chemicals will however need to be substituted if safer alternatives are available and are technically and economically viable. The initial list of chemicals that meet the criteria for 'substances of very high concern' will be issued in 2009.

Despite the years of debate and controversy REACH is finally a reality. REACH is not simply a chemicals industry Regulation, it will affect multiple industries and require management over many years to come. Early preparation is essential to minimise the business risks and to ensure continued access to chemicals. For further information on REACH please go to http://www.reach-answers.com/

To read more articles on Textile, Fashion, Apparel, Technology, Retail and General please visit www.fibre2fashion.com/industry-article