Registration, Evaluation and Authorisation of Chemicals
Encyclopedia
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union
Regulation of 18 December 2006. REACH addresses the production and use of chemical substance
s, 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 affect industries throughout the world. REACH entered into force in 1 June 2007, with a phased implementation over the next decade.
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.
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.
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 . 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.
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. 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.
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. 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'. 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.
under the proposal. Animal tests on vertebrate
s 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. 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.
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.
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”).
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
Regulation of 18 December 2006. REACH addresses the production and use of chemical substance
Chemical substance
In chemistry, a chemical substance is a form of matter that has constant chemical composition and characteristic properties. It cannot be separated into components by physical separation methods, i.e. without breaking chemical bonds. They can be solids, liquids or gases.Chemical substances are...
s, 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 affect industries throughout the world. 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 tonneTonne
The tonne, known as the metric ton in the US , often put pleonastically as "metric tonne" to avoid confusion with ton, is a metric system unit of mass equal to 1000 kilograms. The tonne is not an International System of Units unit, but is accepted for use with the SI...
or more per year to register these substances with a new European Chemicals Agency
European Chemicals Agency
The European Chemicals Agency is an agency of the European Union which manages the technical, scientific and administrative aspects of the Registration, Evaluation, Authorisation and Restriction of Chemicals system...
(ECHA) in Helsinki
Helsinki
Helsinki is the capital and largest city in Finland. It is in the region of Uusimaa, located in southern Finland, on the shore of the Gulf of Finland, an arm of the Baltic Sea. The population of the city of Helsinki is , making it by far the most populous municipality in Finland. Helsinki is...
, Finland
Finland
Finland , officially the Republic of Finland, is a Nordic country situated in the Fennoscandian region of Northern Europe. It is bordered by Sweden in the west, Norway in the north and Russia in the east, while Estonia lies to its south across the Gulf of Finland.Around 5.4 million people reside...
. Because REACH applies to some substances that are contained in objects ('articles' in REACH terminology), any company importing goods into Europe could be affected.
The European Chemicals Agency
European Chemicals Agency
The European Chemicals Agency is an agency of the European Union which manages the technical, scientific and administrative aspects of the Registration, Evaluation, Authorisation and Restriction of Chemicals system...
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
Substance of very high concern
A substance of very high concern is a chemical substance for which it has been proposed that the use within the European Union be subject to authorisation under the REACH Regulation...
' (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.
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 . 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
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
supports businesses affected by REACH by handing out – free of charge – a software application (IUCLID
IUCLID
IUCLID is a software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances. Distributed free of charge, the software is especially useful to chemical industry companies and to government authorities...
), 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
Chemical safety assessment
According to REACH legislation, a chemical safety assessment "has to be performed by registrants for substances manufactured and imported in quantities starting at 10 tonnes per year and by downstream users if their uses are not addressed by their supplier."The CSA includes the evaluation of all...
(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.
History
REACH is the product of a wide-ranging overhaul of EU chemical policy. It passed the first reading in the European ParliamentEuropean Parliament
The European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
on 17 November 2005, and the Council of Ministers
Council of the European Union
The Council of the European Union is the institution in the legislature of the European Union representing the executives of member states, the other legislative body being the European Parliament. The Council is composed of twenty-seven national 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
Euro
The euro is the official currency of the eurozone: 17 of the 27 member states of the European Union. It is also the currency used by the Institutions of the European Union. The eurozone consists of Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,...
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.
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
Dangerous Preparations Directive
The Dangerous Preparations Directive is a European Union directive in the field of occupational safety and health and consumer protection. It complements the Dangerous Substances Directive and replaces a previous Dangerous Preparations Directive...
. It came into force on 20 January 2009, and will be fully implemented by 2015.
Reason behind REACH
The legislation was proposed under dual reasoning: protection of human healthHealth
Health is the level of functional or metabolic efficiency of a living being. In humans, it is the general condition of a person's mind, body and spirit, usually meaning to be free from illness, injury or pain...
and protection of the environment
Natural environment
The natural environment encompasses all living and non-living things occurring naturally on Earth or some region thereof. It is an environment that encompasses the interaction of all living species....
.
Using potentially toxic substances (such as phthalates
Phthalates
Phthalates , or phthalate esters, are esters of phthalic acid and are mainly used as plasticizers . They are used primarily to soften polyvinyl chloride...
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
Consumer
Consumer is a broad label for any individuals or households that use goods generated within the economy. The concept of a consumer occurs in different contexts, so that the usage and significance of the term may vary.-Economics and marketing:...
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 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'. However, many of these substances may bioaccumulate
Bioaccumulation
Bioaccumulation refers to the accumulation of substances, such as pesticides, or other organic chemicals in an organism. Bioaccumulation occurs when an organism absorbs a toxic substance at a rate greater than that at which the substance is lost...
in the human body, thus reaching dangerous concentrations. They may also chemically react
Chemical reaction
A chemical reaction is a process that leads to the transformation of one set of chemical substances to another. Chemical reactions can be either spontaneous, requiring no input of energy, or non-spontaneous, typically following the input of some type of energy, such as heat, light or electricity...
with one another, producing new substances with new risks.
Controversy
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 testingAnimal testing
Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments. Worldwide it is estimated that the number of vertebrate animals—from zebrafish to non-human primates—ranges from the tens of millions to more than 100 million...
under the proposal. Animal tests on vertebrate
Vertebrate
Vertebrates are animals that are members of the subphylum Vertebrata . Vertebrates are the largest group of chordates, with currently about 58,000 species described. Vertebrates include the jawless fishes, bony fishes, sharks and rays, amphibians, reptiles, mammals, and birds...
s 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
Nature (journal)
Nature, first published on 4 November 1869, is ranked the world's most cited interdisciplinary scientific journal by the Science Edition of the 2010 Journal Citation Reports...
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. 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.
On 8 June 2006, the REACH proposal came under criticism from a group of nations including the United States, India and Brazil
Brazil
Brazil , officially the Federative Republic of Brazil , is the largest country in South America. It is the world's fifth largest country, both by geographical area and by population with over 192 million people...
, claiming that the bill would hamper global trade.
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 SIEFs will bring new challenges. An article in the business news service Chemical Watch
Chemical Watch
- Chemical Watch :Chemical Watch is an online journal reporting news and intelligence to help companies meet responsibilities under chemicals legislation...
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”).
See also
- Consumer protectionConsumer protectionConsumer protection laws designed to ensure fair trade competition and the free flow of truthful information in the marketplace. The laws are designed to prevent businesses that engage in fraud or specified unfair practices from gaining an advantage over competitors and may provide additional...
- Environmental healthEnvironmental healthEnvironmental health is the branch of public health that is concerned with all aspects of the natural and built environment that may affect human health...
- International Material Data System
- Pesticides in the European UnionPesticides in the European Union-REACH:REACH is a European Community regulation to improve the protection of human health and the environment. It also calls for the substitution of the more dangerous chemicals with safer alternatives...
- Porter hypothesisPorter hypothesisAccording to the Porter Hypothesis, strict environmental regulations can induce efficiency and encourage innovations that help improve commercial competitiveness...
- Quality of lifeQuality of lifeThe term quality of life is used to evaluate the general well-being of individuals and societies. The term is used in a wide range of contexts, including the fields of international development, healthcare, and politics. Quality of life should not be confused with the concept of standard of...
External links
- List of REACH (Pre-) Registered substances - Online search helper
- 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