REACH starts its pre-registration process next month (June) when producers and importers of chemicals with an output of over one metric ton a year have to provide minimal details of the substances they plan to register. The registration procedure is being stretched over a period of 11 years.
Pre-registration is expected to raise some difficulties for chemical suppliers, particularly the small operators (SMEs) because of the problems of ensuring that chemicals are given the proper identity. This will ensure that companies with the same substances can share the cost of gathering safety data for the full registration.
But it is now becoming clear to coatings companies that the biggest challenge posed by REACH for their sector will be the collection of data on the uses of each individual chemical, which has to be provided for its registration.
A registration dossier has to contain not only information about toxicological and other potentially hazardous properties of the substance but also data on its uses. For chemicals in coatings products that means not only details about their function within different formulations but also information on the way the coating is applied by downstream users.
With chemicals which are manufactured or imported in quantities of ten metric tons or more annually, chemicals safety assessments will have to be conducted on all identified uses. This will involve the drawing up of exposure scenarios giving details of conditions under which a substance is manufactured and then used during its life cycle in terms of the way people and the environment are exposed to it.
The exposure scenarios will not only be an important part of registration dossiers but they will also provide additional safety data and details on risk management in the Safety Data Sheets (SDS) on individual products. One of the main aims behind REACH is that more comprehensive safety information on products should be communicated down the supply chain.
The completion of exposure scenarios could be a formidable task for the coatings sector which is one of the biggest in the EU to be covered by the REACH legislation. This is on account of the numbers and range of chemicals in its formulations and the numbers and diversity of its downstream customers.
Approximately 1,000 paint producing companies, accounting for 85% of the European market by volume, are members of the European Council of the Paint, Printing Ink and Artists' Colours Industry (CEPE), the industry's European trade association. However the actual number of coatings manufacturers could be well over 2,000 because of the many SME producers of decorative and industrial paints.
There are an estimated 250,000 businesses which could be classified as downstream users of paints. A large proportion of these are small operators in the interior decoration segment.
Coatings producers apply a total of approximately 10,000 different products in their formulations, with an average of 20-30 in each one. Large paint manufacturers may utilize as many 3,000 substances while even with small ones the total could be as high as 500. With each chemical there are multiple uses at the formulation and application stages for each of which exposure scenarios may be needed.
The coatings industry had been hoping that the European Commission, the EU's Brussels-based executive, and the European Chemicals Agency (ECHA) in Helsinki, which is responsible for the registration process and the operation of the REACH scheme, would propose ways of simplifying the procedure for exposure scenarios.
When the Commission recently issued a guidance document on exposure scenarios it made the industry even more confused.
"We're not at all happy with this document," said Jacques Warnon, technical manager at CEPE, which has complained to both the Commission and ECHA about it. "It is very long and complex. It is does not give a clear direction to SMEs who are in the most need of guidance."
Now both the industry and the chemical suppliers led by the European Chemical Industry Council (Cefic), the trade association for chemical producers, have decided to come together to provide their own advice and assistance on exposure scenarios.
"The best thing to do is for the industry to work out its own specific guidance on this matter by providing tools to simplify the whole process," said Warnon. "The Commission's guidance is only a set of proposals. We just have to make sure that what we put forward is in line with the REACH legislation."
Both representatives of the coatings sector and of chemical suppliers seem to agree that a system needs to be devised which will enable information about uses and applications of chemicals in paints to be passed easily up and down the supply chain.
"We need to help companies to develop exposure scenarios which can be communicated without difficulty between each part of the chain and the key to doing this is to have a system of standardized data," said Jacques Wille, an IT specialist on REACH at Cefic. It has already started collaborating with chemical distributor organizations on putting together a software program on exposure scenarios.
The solution to the problem of collecting data on uses is seen to be generic exposure scenarios which cover a range of similar applications. Experimental work on generic scenarios has already been carried out by coatings associations in Scandinavian countries and is now been further developed by CEPE.
"It is a complex task," sais Warnon. "We hope to reach a common position with the chemical suppliers so that we can provide guidance to our members on the issue by early next year."
CEPE's target is the drawing-up of tens rather than hundreds of exposure scenarios which will be able to embrace approximately 90% of uses without being too narrow or broad in their scope.
"We will not be able to cover everything," Warnon explained. "There will be specialist uses for which companies will have to develop their own scenarios."
A crucial requirement of the generic scenarios is that they should be short, clear and easy to understand. Otherwise, health and safety experts in the industry warn, workers using paints will not bother to read them.