On the 30th December 2006 the REACH Regulation (EC) No 1907/2006 and Directive 2006/121/EC amending Council Directive 67/548/EEC were published in the EU Official Journal. The regulations are effective across the whole of the EU on the 1st June 2007.
The intentions of the new Regulation are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information has to be passed down the chain of production.
Tthe main REACH requirements start to come into effect from the 1st June 2008 when a 6 months window to pre-register substances comes into effect. The 1st December 2010 is the deadline set for producers and importers to register the following:
- All category 1 and 2 carcinogens, mutagens and reprotoxins produced above 1 tonne
- Substances classed as very toxic to aquatic organisms above 100 tonnes
- All other substances above 1000 tonnes.
Substances not registered by the dealine can not be sold in the EU.
One of the requirements of REACH is to ensure that not only manufacturers and importers but
also their customers, i.e. downstream users and distributors, have the information they need to use chemicals safely. Information relating to health, safety and environmental properties, risks and risk management measures is required to be passed both up and down the supply chain. The primary tool for information transfer is the 'Safety Data Sheet (SDS)
For substances of very high concern, an authorisation is required for their use and their placing on
the market. Substances that fall into this category will be fed into the authorisation system as resources allow. Their uses will not be banned by default. The REACH agency will publish a list of substances meeting the criteria above and reflecting its multiannual work plan, taking into consideration comments from interested parties.
The European Commission confirmed their intention to hold an internet consultation on GHS (Global Harmonised Labelling System). The date is targeted for early August 2006 and will run for 8 to 10 weeks. The plan is that this new system will be launched at the same time as REACH and be the official system within it for the classification & labelling of substances and preparations. Behind this are many concerns in industry. Most prominent are
- this will be a significant undertaking on its own. Combined with REACH there is increased potential for supply chain confusion and increased potential for unintended compliance violations.
- while GHS has been agreed to as the global framework for this form of hazard communication, the EU is an early adopter, which will require additional education and awareness training within supply chains outside of the EU, many of whom will be late adopters (for example : the U.S. will not begin adoption until after 2010). This places a burden on EU companies to review and advise need for corrections/amendments of classification of raw materials supplied from nations not aligned to GHS.
So what does all this mean to the downstream chemicals supply chain? First, there will be changes to the classification and labelling of materials supplied by upstream chemicals suppliers separate from the consequences of REACH. These may be minor or significant, depending on the hazard profile of the substances/preparations involved. This may be a concern for site industrial hygiene etc. Downstream users will need to assess the use and exposure scenarios under REACH and communicate back up the supply chain this information in the context of substances and preparations classified under GHS. So the downstream users will need to be trained and be aware of the new scheme.
The EDT tool covers both REACH and Material Data Sheets. Once the EU position on GHS has been established the tool will be updated to reflect the process decided.
If you want to find out more about REACH then attend our webinar on the 6th March. It is only £50 and we put no restrictions on the number of people listening. These talks are not only ideal for businesses but for universities/colleges that wish their students to keep up to date on these matters and get independant expert advise.
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