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REACH Regulation

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REACH Regulation

European Union 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 L396, 30.12.2006, pp. 1–849
History
Made 18 December 2006
Came into force 1 June 2007
Preparative texts
Commission proposal COM 2003/0644 Final
EESC opinion C294, 25.11.2005, pp. 38–44.
CR opinion C164, 2005, p. 78
EP opinion 17 November 2005
13 December 2006
Other legislation
Replaces 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 (i.e. everything made of atoms), 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.

Overview

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. Since 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 20 June 2013, there are 144 SVHCs on the candidate list for authorization.[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:

  • find each other and start communicating openly and honestly
  • start sharing data
  • start sharing costs in a fair and transparent way
  • democratically and in full consensus take the most complex decisions

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 Requirements

One of the major elements of the REACH regulation is the requirement to communicate information on chemicals up and down the supply chain. This ensures that manufacturers, importers and also their customers are aware of information relating to health and safety of the products supplied. For many retailers the obligation to provide information about substances in their products within 45 days of receipt of a request from a consumer is particularly challenging. Having detailed information on the substances present in their products will allow retailers to work with the manufacturing base to substitute or remove potentially harmful substances from products. The list of harmful substances is continuously growing and requires organizations to constantly monitor any announcements and additions to the REACH scope. This can be done on the European Chemicals Agency's website.[7]

History

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 over 11 years, and the assumed health benefits of saved billions of euro in healthcare costs.[8] However, there have been different studies on the estimated cost which vary considerably in the outcome. It came into force on 20 January 2009, and will be fully implemented by 2015.

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.

Rationale

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 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".[9] However, many of these substances may bioaccumulate in the human body, thus reaching dangerous concentrations. They may also chemically react with one another,[10] producing new substances with new risks.

REACH in non-EU countries

A number of countries outside of the European Union have started to implement REACH-regulations or are in the process of adopting such a regulatory framework to approach a more globalized system of chemicals registration under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).[11] Balkan countries such as Croatia and Serbia are in the process of adopting the EU REACH system under the auspices of the EU IPA programme. Switzerland has moved towards implementation of REACH through partial revision of the Swiss Chemical Ordinance on February 1, 2009. The new Chemicals Management Regulation in Turkey is paving the way for the planned adoption of REACH in 2013. China has moved towards a more efficient and coherent system for the control of chemicals in compliance with GHS.

Controversy

Apart from the potential costs to industry and the complexity of the new law, REACH has also attracted concern because of animal testing. Animal tests on vertebrates are allowed only once per one substance, and where suitable alternatives cannot 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.[12] Hartung is the former head of European Centre for the Validation of Alternative Methods (ECVAM). In a news release, ECHA criticised assumptions made by Hartung and Rovida; ECHA's alternative assumptions reduced sixfold the number of animals.[13]

On 8 June 2006, the REACH proposal was criticized by non-EU countries, including the United States, India and Brazil, which stated that the bill would hamper global trade.[14]

Only Representative

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 Only Representative assumes responsibility and liability for fulfilling obligiations of importers in accordance with REACH for substances being brought into the EU by a non-EU manufacturer.[15]

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").[16]

Example of chemical inventories in various countries/regions

Source:[17]

  • Verordnung (EG) Nr. 1907/2006 (REACH)
  • AICS - Australian Inventory of Chemical Substances
  • DSL - Canadian Domestic Substances List
  • NDSL - Canadian Non-Domestic Substances List
  • KECL (Korean ECL) - Korean Existing Chemicals List
  • ENCS (MITI) - Japanese Existing and New Chemical Substances
  • PICCS - Philippine Inventory of Chemicals and Chemical Substances
  • TSCA - US Toxic Substances Control Act
  • SWISS - Giftliste 1
  • SWISS - Inventory of Notified New Substances

REACH Authorisation List

The European Chemical Agency (ECHA) has published the REACH Authorization List, in an effort to tighten the use of Substances of Very High Concern(SVHC)1. The list is an official recommendation from the ECHA to the European Commission.[18] The list is also regularly updated and expanded, and currently comprises a total of 144 SVHC.

To sell or use these substances, manufacturers, importers and retailers in the European Union (EU) must apply for authorization from the ECHA. The applicant is to submit a chemical safety report on the risks entailed by the substance, as well as an analysis of possible alternative substances or technologies including present and future research and development processes.

See also

References

External links

  • European Chemicals Agency - The organization responsible for implementing REACH
  • European Commission: "What is REACH"
  • European Commission REACH & GHS overview - for enterprise and industry
  • Database of REACH consortia - Chemical Watch
  • Development of a mechanistic model for the Advanced REACH Tool, TNO Report
  • ECHA Guidance on REACH implementation
  • Advanced REACH Tool (ART)
  • Institute of Occupational Medicine fact sheets
  • REACH and nanomaterials
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