Table of Contents
HazMat Course Module 9
LEGISLATION PERTAINING TO CHEMICAL CONTROL
Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) is a new European Union Regulation, EC/2006/1907 of 18 December 2006. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will impact industries throughout the world. REACH entered into force in June 2007, with a phased implementation over the next decade.
When REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with a new European Chemicals Agency in Helsinki, Finland. Because REACH applies to some substances that are contained in objects ('articles' in REACH terminology), any company importing goods into Europe could be affected.
Potential registrants (i.e. manufacturers and importers of chemical substances) must 'pre-register' these substances by December 1, 2008, in order to benefit from postponed 'phase in' deadlines. Although 'pre-registering' is not mandatory, it is free and an important step in allowing potential registrants much more time before they have to fully register.
Supply of substances to the European market which have not been registered as required is illegal (known in REACH as 'no data, no market').
REACH also addresses the continued use of chemical 'Substances of Very High Concern' (SVHC) because of their potential negative impacts on human health or the environment. The European Chemicals Agency may need to be notified of the presence of SVHCs in articles, if they are present above certain tonnage and concentration thresholds. Depending on the substance in question and its use, producers and importers may then be obliged to investigate its effects on human health and the environment.
A shortlist of some SVHCs will be subjected to new controls under REACH - this is called 'authorization'. This shortlist will be created as an annex to the Regulation (Annex XIV), and will be drawn from lists of SVHCs published over the next year. Continued use of Annex XIV substances will have to be justified on a case-by-case basis, and applications for authorization must include plans to replace use of an Annex XIV substance with a safer alternative (or, if no safer alternative exists, the applicant must work to find one) - known as 'substitution'.
The European Chemicals Agency can deny authorization, making continued use illegal.
REACH applies to all chemicals imported or produced in the EU, in contrast to the US Toxic Substances Control Act which only applies to chemicals newly coming into use. The European Chemicals Agency will manage the technical, scientific and administrative aspects of the REACH system.
The European Commission supports businesses affected by REACH by handing out - free of charge - a software application (IUCLID), which simplifies capturing, managing and submitting of data on chemical properties and effects.
REACH is the product of a wide-ranging overhaul of EU chemical policy. It passed the first reading in the European Parliament on 2005-11-17, and the Council of Ministers reached a political agreement for a common position on 2005-12-13. The European Parliament approved REACH on 2006-12-13 and the Council of Ministers formally adopted it on 2006-12-18. Weighing up expenditure versus profit has always been a significant issue, with the estimated cost of compliance being around 5 billion euro over 11 years, and the assumed health benefits of saved billions of euro in healthcare costs. However, there have been different studies on the estimated cost which vary considerably in the outcome.
The European Union is currently developing a separate law to regulate the classification, labelling and packaging of substances and mixtures, which will implement in Europe the worldwide standards for providing information about chemicals on labels, set out in the United Nations Globally Harmonised System of the Classification and Labelling of Chemicals (UN GHS). The new European Regulation will complement REACH.
Reason behind REACH
Using potentially toxic substances (such as phthalates or brominated flame retardants) is undesirable and REACH will force the use of certain of these substances to be phased out. Using potentially toxic substances in products other than those ingested by humans (such as electronic devices) may seem to be safe, but there are several ways in which chemicals can enter the human body and the environment. Substances can leave articles during consumer use, for example into the air where they can be inhaled or ingested. Even where they might not do direct harm to humans, they can contaminate the air or water, and can enter the food chain through plants, fish or other animals. According to the European Commission, little safety information exists for 99 percent of the tens of thousands of chemicals placed on the market before 1981.There were 100,106 chemicals in use in the EU in 1981, when the last survey was performed. Of these only 3,000 have been tested and over 800 are known to be carcinogenic, mutagenic or toxic to reproduction. These are listed in the Annex 1of Directive [67/548/EEC].
Continued use of many toxic chemicals is sometimes justified because 'at very low levels they are not a concern to health'. However, many of these substances may bioaccumulate in the human body, thus reaching dangerous concentrations. They may also chemically react with one another, producing new substances with new risks.
Apart from the potential costs to industry and the complexity of the new law, REACH has also attracted concern because of the potential for a very significant increase in animal testing under the proposal.
Animal tests on vertebrates are allowed only once per one substance, and where suitable alternatives can't be used. If a company pays for these tests, it must sell the rights to the results for a “reasonable” price (although this is not defined). There are additional concerns that access to the necessary information may prove very costly for potential registrants needing to purchase this.
On June 8, 2006 the REACH proposal came under criticism from a group of nations including the United States, India and Brazil claiming that the bill would hamper global trade.
Member State Committee of ECHA unanimously agreed on the identification of 14 Substances of Very High Concern (SVHC) that may become subject to authorisation at its meeting in Helsinki of 7 and 8 October 2008.
Reach enters second phase
The EU's massive Reach scheme for the registration, evaluation and authorisation of chemicals passed its first milestone at midnight on 1 December 2008, when the pre-registration process closed.
Any chemical not pre-registered under the legislation before this deadline cannot be sold on the European market after 1 January 2009, no matter where it is made.
The Helsinki-based European Chemicals Agency (ECHA), the body responsible for administering Reach, says it successfully handled a late rush of submissions. The process required companies to give brief details of each of the chemicals they may market, with data on the manufacturer or importer.
Reach covers all chemicals with an output of over 1 tonne or more introduced into the EU market before 1981 (when a more rigorous approval method was enforced). The idea is to subsume a hotchpotch of different directives under more up-to-date testing requirements. The number of chemicals affected was originally estimated to total around 30,000.
The European Commission, to which ECHA is accountable, had originally estimated at the beginning of the six- month pre-registration process in June that there would be around 180,000-200,000 pre-registrations. This turned out to be a massive underestimate. A week after the pre-registration deadline the number had reached 2.6 million with the final total likely to be much higher because of the quantity of submissions still needing to be sorted.
Because of the underestimate ECHA had been faced with the prospect of having to deal with large numbers of late submissions, averaging around 200,000 a day. It even drew up a backup plan which would enable companies to bypass its Reach-IT computer system for the process by sending information by email.
'Half of the submissions arrived during the last three weeks,' says an ECHA spokesman. 'ECHA received about fifteen times more pre-registrations than expected,' he added. 'This was mainly caused by several companies submitting all existing substances and taking the precaution to double pre-registrations of the same substance in their supply chain.'
BASF, the world's largest chemicals company with a portfolio of around 8000 products, submitted around 40,000 pre-registrations, mainly for similar products both produced in Europe and reimported from non-EU countries. Speciality chemicals distributor Azelis pre-registered more than 100,000 chemicals to make sure that no mixtures of substances could be banned.
Following the end of pre-registration, registration proper begins in 2009. Each pre-registrant is now allocated a substance information exchange forum (SIEF) in which producers, importers and purchasers will share information on the same substance in order to draw up a single dossier for its registration. Substances have been given different deadlines for their registration based on the total annual tonnage of their outputs.
The immediate difficulties will be to ensure that pre-registrants have been placed in the right SIEFs, and sorting out whether different companies have registered their substances correctly. With some SIEFs thought to contain more than 2000 members, some splitting up may be in order. After that, collaboration between SIEF members begins, with companies expected to share safety data such as animal toxicity tests. Companies will also have the right to opt out of sharing some chemical data on the grounds of confidentiality.
Describe the chemical control legislation in your country.