Category Archives: REACH Regulations

Further information on REACH and how it affects you.

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Under REACH, not all chemicals are treated the same way. The data required for registration depends on the quantity produced or imported, (> or < 1 tonne per year). The most hazardous chemicals are considered differently and will be classified as “Substances of Very High Concern” (SVHCs). These will include those that are toxic, carcinogenic, mutagenic, reproductive toxins and harmful to the environment.

These may need to be “authorised” before they can be used and authorisation will not be given if there are safer alternatives or if the substance cannot be safely controlled.

REACH includes metals and alloys, but not polymer plastics (although any residual monomer and any additives contained within them may need to be registered).

So what should you do now?

As all commercial users of chemicals are be affected by REACH, it is recommended that a strategy is defined and followed. This should start now and a perfect place to get help is with a company specialising in MSDS (Material Safety Data Sheet) software.

Most manufacturers use chemicals and preparations of one type or another.  As a starting point, manufacturers should audit their own business and production processes to answer the following questions:

* Do you manufacture or import any substances from outside the EU in quantities of 1 tonne or more per year?
* Do you import articles from outside the EU that contain 1 tonne or more of an intentionally released substance?
If you answered yes to either of these questions then these chemicals require registration.

Some more questions:
Do any of your products contain SVHCs?  – If the answer is yes, you will need to provide information to your customers.

Do any of the chemicals, preparations or materials you use contain a substance likely to be classified as a SVHC? – If the answer is yes, then there is a risk that this may be withdrawn from the market without warning.

Therefore it is best to avoid the use of materials containing SVHCs in new products unless there is no alternative.  Additionally, SVHCs may not be allowed in products, even in small quantities, after dates that will be specified unless they have been authorised. Users as well as manufacturers and importers can request authorisation but should seek professional advice first.

The next step is to contact your materials suppliers to ask them following questions:
Can your suppliers confirm that REACH will not affect the supply of materials that you currently use? It is likely that they will not be able to confirm this but your question will encourage them to find out what plans their suppliers have and warn you of withdrawals as soon as possible.

Do your suppliers require information on how you use their products? If you use chemicals in an unusual way, you may want to provide details. Remember that if your use is not included in the exposure scenario that is written by the registrant, you cannot continue to use it in this way unless you submit your own chemical safety report to the ECHA.

Have they provided an up-to-date copy of the MSDS data sheet and do they have processes to automatically update you if the content changes?  This facility for automatic updating of the MSDS can save massive time and expense consequences to your supply stream.

You should also be prepared to answer questions from your customers who may want information on your plans or about chemicals present in your products.

REACH Regulations: The Background

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The EU REACH regulations came into force on 1st June 2007. REACH is a regulation which many companies in the European Union (EU) will have to comply with.

REACH stands for:
Registration – the necessity to submit a (technical) dossier on the properties of a substance.
Evaluation – of the dossier by the authorities.
Authorisation and restriction – on the use of a substance or
preparation of CHemicals.

REACH was introduced because many thousands of chemicals are used in the EU,  some in very large quantities, but the risks to human health and to the environment from many of these are not widely known. REACH intends to address this by making manufacturers and importers of chemicals responsible for producing data to define the  hazards and risks from around 30,000 substances that are manufactured or imported in  quantities of 1tonne or more per year in the EU.

The number of incidents of allergies, asthma, certain types of cancer, and re-productive disorders are on the increase in Europe and chemicals are considered as one possible cause.  If REACH succeeds in reducing chemical-related diseases by only 10%, the  health benefits are estimated at €50 billion over 30 years. 100,106 chemicals were reported to be on the market in 1981, the only time that chemicals have been listed in the EU. The chemicals sector is the third largest manufacturing industry in the EU, encompassing 31,000 companies and 1.9 million people.

Internationally, the EU is the leading chemicals producing area, its €580 billion representing 33% of global sales. For 99% of chemicals (by volume), information on properties, uses and risks is sketchy. There is no data for about 21% of them, and another 65% come with insufficient data. Only 3% have been fully tested The costs of registration, including the necessary testing, are estimated at €2.3 billion over the 11 years that that it will take to register all the substances covered by REACH.

The total costs, including those to downstream users, are estimated at €2.8 billion to €5.2 billion, depending on the extent to which registration costs will increase prices of  chemicals and the costs of substituting chemicals that will be withdrawn.