The REACH Regulation is the result of an in-depth review of the EU's chemical policy. It passed the first reading of the European Parliament on 17 November 2005, and the Council of Ministers reached political agreement for a common position on 13 December 2005. The European Parliament approved the REACH Regulation on 13 December 2006 and the Council of Ministers formally adopted it on 18 December 2006. Of particular importance has been balancing expenditure and benefit, with an estimated cost of compliance of around €5 billion. euros over 11 years, and assumed health benefits of billions of euros saved in healthcare costs.[6]​ In any case, there are different studies in which cost estimates vary considerably in terms of their results.

A separate regulation - the CLP Regulation - implements the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS), to which it adds some particularities not considered by the UN in the form of EUH risk phrases.[7]​[8]​ It will gradually replace the previous Substances Directive. Dangerous Preparations Directive) came into force on January 20, 2009, and will be fully implemented by 2015.

The legislation was proposed for a two-fold reason: the protection of human health and the protection of the ecosystem.

The use of potentially toxic substances (such as phthalates or brominated flame retardants) is undesirable and the REACH Regulation will require that the use of these substances be superseded. The use of potentially toxic substances in products other than those ingested by humans (such as electronic devices) may seem safe, but there are several ways in which chemicals can enter the human body and ecosystem. Substances can leave articles during consumer use, for example into the air when they can be inhaled or ingested. Even when they may not directly harm 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, there is little information on 99 percent of the tens of thousands of chemical substances on the market before 1981.[4] In 1981 there were 100,106 chemical substances in use in the EU, when the last inventory was carried out. Of them, only 3,000 have been tested and around 800 are known to be carcinogenic, mutagenic or toxic to reproduction. These are those listed in Annex 1 of the Dangerous Substances Directive (now Annex 3 of the CLP Regulation).

The continued use of many toxic chemicals is sometimes justified because 'at very small concentrations they do not compromise health'.[9]​ However, many of these substances can bioaccumulate in the human body, thus reaching dangerous concentrations. They can also react chemically with each other,[10]​ producing new substances that carry new risks.

Aside from the potential costs to industry and the complexity of the new law, the REACH Regulation has also attracted attention given its potential for a very significant increase in animal testing in its proposal.[11] Animal testing on vertebrates is permitted only once per substance and when suitable alternatives cannot be used. If a company pays for these experiments, it must sell the rights to these results at a "reasonable" price (although this is not defined). There is an added concern that access to the necessary information may be very costly for potential registrants, requiring purchase.

On June 8, 2006, the proposed REACH Regulation was criticized by a group of nations that included the United States, India and Brazil, arguing the proposal could hinder global trade.[12]

Many 'pre-registrations' appear to have been carried out by consulting services as "exclusive representation" of importers. Some consultancies have also been designated as facilitators of the Substance Information Exchange Forum (SIEF).

Some SIEFs will provide new challenges. Some 'pre-registrants' may simply be consultancies waiting for work, while others may be looking to charge exorbitant amounts for the data they have to offer.[13]​.

The REACH Regulation is the result of an in-depth review of the EU's chemical policy. It passed the first reading of the European Parliament on 17 November 2005, and the Council of Ministers reached political agreement for a common position on 13 December 2005. The European Parliament approved the REACH Regulation on 13 December 2006 and the Council of Ministers formally adopted it on 18 December 2006. Of particular importance has been balancing expenditure and benefit, with an estimated cost of compliance of around €5 billion. euros over 11 years, and assumed health benefits of billions of euros saved in healthcare costs.[6]​ In any case, there are different studies in which cost estimates vary considerably in terms of their results.

A separate regulation - the CLP Regulation - implements the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS), to which it adds some particularities not considered by the UN in the form of EUH risk phrases.[7]​[8]​ It will gradually replace the previous Substances Directive. Dangerous Preparations Directive) came into force on January 20, 2009, and will be fully implemented by 2015.

The legislation was proposed for a two-fold reason: the protection of human health and the protection of the ecosystem.

The use of potentially toxic substances (such as phthalates or brominated flame retardants) is undesirable and the REACH Regulation will require that the use of these substances be superseded. The use of potentially toxic substances in products other than those ingested by humans (such as electronic devices) may seem safe, but there are several ways in which chemicals can enter the human body and ecosystem. Substances can leave articles during consumer use, for example into the air when they can be inhaled or ingested. Even when they may not directly harm 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, there is little information on 99 percent of the tens of thousands of chemical substances on the market before 1981.[4] In 1981 there were 100,106 chemical substances in use in the EU, when the last inventory was carried out. Of them, only 3,000 have been tested and around 800 are known to be carcinogenic, mutagenic or toxic to reproduction. These are those listed in Annex 1 of the Dangerous Substances Directive (now Annex 3 of the CLP Regulation).

The continued use of many toxic chemicals is sometimes justified because 'at very small concentrations they do not compromise health'.[9]​ However, many of these substances can bioaccumulate in the human body, thus reaching dangerous concentrations. They can also react chemically with each other,[10]​ producing new substances that carry new risks.

Aside from the potential costs to industry and the complexity of the new law, the REACH Regulation has also attracted attention given its potential for a very significant increase in animal testing in its proposal.[11] Animal testing on vertebrates is permitted only once per substance and when suitable alternatives cannot be used. If a company pays for these experiments, it must sell the rights to these results at a "reasonable" price (although this is not defined). There is an added concern that access to the necessary information may be very costly for potential registrants, requiring purchase.

On June 8, 2006, the proposed REACH Regulation was criticized by a group of nations that included the United States, India and Brazil, arguing the proposal could hinder global trade.[12]

Many 'pre-registrations' appear to have been carried out by consulting services as "exclusive representation" of importers. Some consultancies have also been designated as facilitators of the Substance Information Exchange Forum (SIEF).

Some SIEFs will provide new challenges. Some 'pre-registrants' may simply be consultancies waiting for work, while others may be looking to charge exorbitant amounts for the data they have to offer.[13]​.