Directive Decoder

The main emphasis is on the most dangerous substances and on those used in the largest quantities. The lower limit is 1 tonne per annum per producer. Therefore, if you are an importer of a substance that has a specific use, and if you use less than 1 tonne per annum, there is no need to register although you should pre-register if you expect sales to exceed 1 tonne in the future.

Usually chemical manufacturers will register but equipment producers will be affected. They should at least ensure that their suppliers have registered all of the chemicals they use and specified how they are used and in what applications. Manufacturers who import unusual chemicals for their own use (>1 tonne p.a.) will need to register these materials.

Essentially, most substances will need to be registered (there are some exemptions) otherwise they cannot be used. Certain more dangerous substances that will be classified as “Substances of Very High Concern” (SVHC) will need to be authorised before they can be used and authorisation will not be given if alternatives exist.

When chemicals are registered, it will be necessary to submit toxicological information, physical properties data, information on environmental effects etc, to the European Chemicals Agency (ECHA). Where this data does not already exist, it will be necessary for the manufacturer or importer to generate this data and it could be very expensive. Industry predictions are that the cost of producing data for a substance (if >1000 tonnes per annum is used) that has no existing data available, could be as much as €2.8 million. If future profits do not justify this expense, the chemical will be removed from the EU market and there are already indications that some chemicals will be withdrawn, rather than registered. The result will be that materials and preparations are suddenly withdrawn from the market.

What precautions can design engineers take to guard against this? It will not be easy but measures include:
• Determine the composition of materials and preparations and whether any ingredients are unusual and so might be withdrawn. Chemicals used in very large quantities (this could be by other industry sectors) will almost certainly be registered, even if the data has to be generated and so are unlikely to be withdrawn. Ask suppliers if the substances and preparations that you use will be registered and continue to be sold in EU. They are under no obligation to tell their customers and may evade the question. Where there is doubt it might be worthwhile considering alternatives should the current material be withdrawn. It is known that some chemical suppliers are planning to withdraw certain chemicals although they will not publicly admit that this is the case.

• REACH could add more substance restrictions. These are likely for any substance that is regarded as a SVHC, which include carcinogens and toxic substances. Examples will almost certainly include lead, cadmium, mercury, arsenic, beryllium as metals and their compounds. REACH will affect the use of SVHCs in production processes (solvents, plating chemicals, etc.) as well as when they are present in finished products. One example is hexavalent chromium which is a carcinogen and is used for hard chrome plating although there is no hexavalent chromium present in the product, only chromium metal. It is worthwhile avoiding any substance that might be regarded as a SVHC if this is possible in both the production processes for making new products and in finished goods, even if they are not currently restricted by RoHS or the Marketing and Use Directive. It is likely that REACH would impose significant costs even if restrictions are limited.

• European manufacturers may consider avoiding the cost of REACH by manufacturing finished products outside of Europe. This will certainly avoid the need to consider process chemicals but REACH also includes substances that are intentionally released by a product or if release is foreseeable. The interpretation of this requirement is not yet totally clear but may extend to substances that are present and are released during recycling at end-of-life. Lead in glass, ceramics or solders in equipment will not be released in normal use but can possibly be released during recycling processes and, as this is foreseeable, it could mean that the lead will need to be registered and also authorised if it is classified as a SVHC. If alternative materials or processes exist, SVHC authorisation will not be granted and so designers should try to find substitute materials wherever possible in new products, even if they are not manufactured in Europe. Registration of all “releasable” substances may also be required.

When considering the design of a new product such as a printer as an example, there are several issues to consider:
• The ink in the print cartridge is a “preparation” and so will need to be registered.
• Many chemicals and preparations are used to manufacture the product; solvents, inks, paints, coatings, etc. Ensure that the suppliers have registered all of these materials, and that there are no chemicals present that are likely to be withdrawn, or will be classified as SVHCs.
• The printer will be recycled at end-of-life and this will release mainly metals; tin, lead, copper, etc. If the authorities decide that release as a result of recycling is in scope of REACH, then as some of these could be SVHCs, they will need to be authorised before they can be used. Check that suppliers have registered all substances that will be released during recycling.

Directive Decoder