| European Union regulation: | |
| Regulation (EC) No 1907/2006 | |
|---|---|
| Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency | |
| Made by | European Parliament and Council |
| Made under | Art. 95 (EC) |
| Journal reference | |
| History | |
| Made | 18 December 2006 |
| Came into force | 1 June 2007 |
| Preparative texts | |
| Commission proposal | COM 2003/0644 Final |
| EESC opinion | C112, 30.4.2004, p. 92 C294, 25.11.2005, pp. 38–44. |
| CR opinion | C164, 2005, p. 78 |
| EP opinion | 17 November 2005 13 December 2006 |
| Other legislation | |
| Replaces | Reg. (EEC) No 793/93 Reg. (EC) No 1488/94 Dir. 76/769/EEC Dir. 91/155/EEC Dir. 93/67/EEC Dir. 93/105/EEC Dir. 2000/21/EC |
| Amends | Dir. 1999/45/EC |
| Amended by | Reg. (EC) No 1272/2008 |
| Status: Current legislation | |
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union Regulation of 18 December 2006.[1] 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[2] and the most important in 20 years.[3] It is the strictest law to date regulating chemical substances and will affect industries throughout the world.[4] REACH entered into force in 1 June 2007, with a phased implementation over the next decade.
Contents |
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 (ECHA) 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.[4]
The European Chemicals Agency has set three major deadlines for registration of chemicals. In general these are determined by tonnage manufactured or imported, with 1000 tonnes/a. being required to be registered by 1 December 2010, 100 tonnes/a. by 1 June 2013 and 1 tonne/a. by 1 June 2018. In addition, chemicals of higher concern or toxicity also have to meet the 2010 deadline.
About 143,000 chemical substances marketed in the European Union were pre-registered by the 1 December 2008 deadline. Although pre-registering was not mandatory, it allows potential registrants much more time before they have to fully register. Supply of substances to the European market which have not been pre-registered or registered 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. From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one tonne per year and the SVHC is present at more than 0.1% of the mass of the object. Some uses of SVHCs may be subject to prior authorisation from the European Chemicals Agency, and applicants for authorisation will have to include plans to replace the use of the SVHC with a safer alternative (or, if no safer alternative exists, the applicant must work to find one) - known as 'substitution'. As of March 2009, there are fifteen SVHCs.[5]
REACH applies to all chemicals imported or produced in the EU. The European Chemicals Agency will manage the technical, scientific and administrative aspects of the REACH system.
To somewhat simplify the registration of the 143,000 substances and to limit vertebrate animal testing as far as possible, Substance Information Exchange Forums (SIEFs) are formed amongst legal entities (such as manufacturers, importers, and data holders) who are dealing with the same substance [6]. This allows them to join forces and finances to create 1 registration dossier. However, this creates a series of new problems as a SIEF is the cooperation between sometimes a thousand legal entities, which did not know each other at all before but suddenly must:
in order to complete a several thousand end points dossier in a limited time.
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. Such submission is a mandatory part of the registration process. Under certain circumstances the performance of a Chemical Safety Assessment (CSA) is mandatory and a Chemical Safety Report (CSR) assuring the safe use of the substance has to be submitted with the dossier. Dossier submission is done using the web-based software REACH-IT.
REACH is the product of a wide-ranging overhaul of EU chemical policy. It passed the first reading in the European Parliament on 17 November 2005, and the Council of Ministers reached a political agreement for a common position on 13 December 2005. The European Parliament approved REACH on 13 December 2006 and the Council of Ministers formally adopted it on 18 December 2006. 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.[7] However, there have been different studies on the estimated cost which vary considerably in the outcome.
A separate regulation – the CLP Regulation (for "Classification, Labelling, Packaging") – implements the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and will steadily replace the previous Dangerous Substances Directive and Dangerous Preparations Directive. It came into force on 20 January 2009, and will be fully implemented by 2015.
The legislation was proposed under dual reasoning: protection of human health and protection of the environment.
Using potentially toxic substances (such as phthalates or brominated flame retardants) is deemed 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.[4] 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 1 of the Dangerous Substances Directive (now Annex 3 of the CLP Regulation)
Continued use of many toxic chemicals is sometimes justified because 'at very low levels they are not a concern to health'.[8] However, many of these substances may bioaccumulate in the human body, thus reaching dangerous concentrations. They may also chemically react with one another,[9] 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.[10] 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 of 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.
An opinion in Nature in 2009 by Thomas Hartung and Constanza Rovida estimated that 54 million vertebrate animals would be used under REACH and that the costs would amount to 9.5 billion Euros.[11] Hartung is the former head of European Centre for the Validation of Alternative Methods (ECVAM). ECHA responded by criticising the assumptions made in Hartung and Rovida's calculations, causing them to overestimate the number of animals used by a factor of 6.[12]
On 8 June 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.[13]
Non-EU consultancies offer “Only Representative” services, though according to REACH it is not possible to register a substance if your “Only Representative” consultancy company is not based in the EU, unless it is subcontracted to an EU-based registrant.
Only Representatives are EU based entities that must comply with REACH (Article 8) and should operate standard, transparent working practices.
The SIEFs will bring new challenges. An article in the business news service Chemical Watch described how some ‘pre-registrants’ may simply be consultants hoping for work (“gold diggers”) while others may be aiming to charge exorbitant rates for the data they have to offer (“jackals”).[14]