In February 2001, the European Commission published a White Paper proposing a new approach to the regulation of chemicals.  This describes a process now known as REACH (Registration, Evaluation and Authorisation of Chemicals).  The objective of this process is to ensure a reasonable level of understanding of the hazards and risks of all new and existing substances.  To meet this proposal, a considerable amount of work will need to be performed by industry in terms of testing and risk assessment.  

The schedule of implementation is that a pre-registration process will be started in June 2008 and completed by November 30 2008 using the REACH IT software from the new Central Chemical Agency in Helsinki.  This first phase is intended to enable organisations supplying chemicals in all industries to declare their interest with specific chemicals as part of an initial evaluation of who is supplying which substance.  These interested parties will then be put together in a SIEF (Substance Information Exchange Forum) with a view that animal data is shared and there is cooperation to work together on joint Registrations.

‘High risk’ substances (Over 1000 tonnes per annum, CMR, PBT or vPvB*) are considered priority substances and it is aimed to complete registration by 2010.  The next volume thresholds of concern are > 100 tonnes and >1 tonnes and these are planned to be registered by 2013 and 2018 respectively – the schedule for evaluation may not be as short.

* CMR = Carcinogenic, Mutagenic and toxic for Reproduction

   PBT = Persistent, bioaccumulative and toxic in the environment (R50 or R51 and R53)

 vPvB = Very persistent, very bioaccumulative
 

More information is given on the CSR page 

Existing substances

The main reason for REACH, other than consolidating existing chemical supply legislation, is to ensure that the many thousands of chemicals being supplied are adequately assessed for potential hazard and risk. 

Although a number of substances have to date been assessed (including those considered hazardous listed on Annex I to Directive 67/548/EEC and its amendments), the criteria for making this assessment has not necessarily been consistent and there are many substances in common use by the general public that have not been adequately assessed.

The first phase of the process will be to list chemicals requiring Registration (pre-registration phase) and to collate animal test data and encourage the formation of Substance Information Exchange Fora (SIEFs).  A major reason for this part of the process is to avoid duplicating animal test work.  It is proposed that substances will be prioritised for registration by calling up those thought to be CMR, PBT vPvB or considered high risk due to large volumes being supplied. 

The mechanism for registration is expected to be based on the IUCLID 5 software, simliar to that previously used for priority existing substances. This is now available to download from the European Chemical Agency (ECHA) web-site (http://ec.europa.eu/echa/home_en.html); this may seem complicated, but it is worth doing even if only to have an idea of the data input requirements that will be expected.  Simple instructions are given on a separate page, but help should be sought form the IUCLID Helpdesk - personal use of this helpdesk had reuslted in rapid and comprehensive support.

There will be a base-set of data required for Registration, with a Chemical Safety Report (CSR - risk assessment) based on Exposure Scenarios.  Higher tiers of data requirements will be based on risk; this being a function of hazards identified in the base-set, the volume supplied and the level of exposure to man and the environment.  Effectively, the requirements that have been imposed for the Notification of New Substances over 1 tonne per annum are expected to be imposed on existing substances supplied over 10 tonnes.

Once substances are Registered, they will be assessed for hazard and risk and further test work or risk evaluation could be required.  If necessary, the use of the substance will be restricted to reduce the risk of exposure to certain groups of the population or to the environment.

Biocidal products, plant protection product, medicines and other materials regulated to a higher levels are exempt from REACH.  Polymers are exempt, but monomers and other constituents will need to be registered substances. 

New substances

The current system of Notification will cease to exist and new substances will be treated in the same way as any other substance being Registered.  In reality, the process will remain very similar with a base-set of data being provided along with details of product and use, backed up with a risk assessment.  The supply thresholds for testing will change so that at 1 tonne, data currently required for 100 kg will be sufficient and the existing base-set will be required at 10 tonnes per annum. 

Substances supplied below 1 tonne will not need Registration, but supply legislation will still apply; such as SDS, classification, correct labelling etc. 

Products being supplied for research or process research (PORDs) will have similar level of exemption as currently exists.  There will be a slightly more relaxed system to permit longer trial periods using higher volumes.  The new system will be known as PPORD (Production and Process Orientated Research and Development).  PORDs still in place in May 2008 will need to be renewed under REACH in June 2008 - current understanding is that ECHA will accept written requests for PPORDs from late May 2008 and if the applicant has not had a response, supply for the reseach and process development purposes outlined in their application can continue.

Family groupings

To reduce the level of new testing, similar substances will be possible to group together into ‘family groupings’.  Guidelines are already been drawn up to help decisions on how such groupings should be determined, but this will rely on the principles of ‘read-across’ of data between substances with similar structures, functional groups or molecular weights.

Consortia formation

As indicated above, those registering the same substance (or substances considered to be in the same family group) will be expected to minimise animal testing by sharing existing data or working together for new testing.  Obviously, non-animal test data can also be shared, although it will be necessary to demonstrate through chemical analysis that the substances are suitably similar to permit sharing (ie. certain sources of material do not contain high levels of hazardous impurities).

It will be up to industry to work together and agree how costs will be shared.  This will impose considerable administrational burden on registrants.

Risk assessment

As well as collecting hazard data and confirming classification, registrants will need to prepare a Chemical Safety Report (CSR) that is effectively a risk assessment that takes into account synthesis and use scenarios.  The current methods for risk assessment for new and existing substances will continue to be used, but new exposure scenarios are being prepared to help harmonise the approach.

For dangerous substances, the authorisation for supply will be limited to use scenarios described in the risk assessment and if customers (downstream users) want to use the substance for other purposes, the new uses will need to be assessed.  This means that there needs to be good communication through the supply lines.

 Downstream users

Downstream users (DUs) will be responsible for ensuring that they use the registered substance in a way covered in the registration and evaluation of the substance.  There is expected to be scope for DUs to be able to prepare CSRs and submit directly to the CA if the use is considered to be commercially sensitive.  Either way, users will need to ensure that they fully understand the conditions of supply and have performed their own assessments of potential risk.  Many organisations outside the core chemical industry will need to get involved in chemical legislation for the first time.

DUs, especially small users of chemicals, will also be vulnerable to substances being withdrawn from the market if registrants cannot justify the cost of testing.

Global Harmonised System (GHS) for Classification and Labelling

GHS is a UN initiative to harmonise the labelling of chemicals throughout the World.  Most of the World has signed up to move to this including Europe and the US – in Europe, implementation will be integrated into the REACH process.   GHS will change some of the criteria for labelling as Hazardous with new thresholds.  As well as a new style of warning symbol, there will be a new symbol for systemic toxic effects – otherwise, many of the symbols will be recognisable to existing EU symbols.

Safety Data Sheets (SDSs)

Other than changes to reflect GHS classification, there are some changes planned to SDS format and content; the main format change is to switch sections 2 and 3 to promote ‘hazard identification’ higher up the front page.

However, a more subtle change required is to ensure that the SDS is relevant to the use of the recipient and it should contain details of agreed Risk Reduction Measures (RRM) for materials that are considered dangerous. 

 Implication for industry

Although the main concern being voiced by industry is the potential high costs for laboratory testing, the greatest impact for industry will be the administrative burden in preparing the registration documents, organising data-sharing and exchanging information with suppliers and customers for risk assessment.  The direct costs for testing may themselves be reduced by estimating data through use of predictive software or comparison with similar substances (family approach).  There is also a strong political will to ensure that the burden of animal testing is kept to a minimum.

The greatest threats perceived by industry, other than direct and indirect costs, are that competitors will have an advantage over them or if the supply of certain chemicals will are not supported by their suppliers leaving users vulnerable.   Interestingly, research among European organisations suggest a fear that non-EU industry will be at an advantage in terms of World trade, but non-EU industry worry that REACH will introduce a closed market in Europe.  Reality may lie between the two.

On the practical level, all suppliers will need to introduce a new form of classification and labelling under GHS and revise SDSs to take into account enhanced requirements to communicate hazard and risk.  This alone is a major logistical problem.

 Action for industry

Even before the REACH Regulation and its technical Annexes are finalised, there is plenty of action that can be taken by industry.  Most of this is no more that what could be considered good product stewardship or good commercial practice.

• Ensure that all substances synthesised or imported onto your site are known and an inventory is prepared, even if imported in the form of mixtures or in articles.  These are the substances that will require Registration.
• Ensure that all substances brought onto your site, either as raw materials, solvents, cleaners, catalysts etc are listed.  The function of each of these should also be known as their use will need to be part of a future risk assessment. 
• Check if you are the only main customer for any materials brought onto site; if so, your supplier may not support a Registration and supply could stop.  How vulnerable are you to products being withdrawn?
• Consider particular risks associated with any substance used on site
• Consider the use of products sold and the risks faced by your customers or consumers.  Have your customers considered risks and if not, remind them that under REACH, all down-stream users will need to ensure that the use of chemicals products is within the scope of the product registration.
• Identify competitors and perhaps consider sharing data.  There will be a compulsion to share animal test data and there may even be a need to make joint registrations.
• Identify substances similar to those you may need to register or conduct risk assessments for.  Can information be shared within family groups of chemicals.
• If, importing, will your supplier appoint an Only Representative

These above points are just simple guidance and only start to scratch the surface of the administrational demands of REACH.  For a general informationon what REACH may mean in practice, REACH Uncovered is an attempt to strip some of the mystique away from the process.

Further details can be found on European Chemical Bureau web-site  http://ecb.jrc.it/ or on the REACHReady website www.reachready.co.uk

Alternatively, please e mail or call us for more advice (tel +44 1943 8654480). info@denehurst.co.uk

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