Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 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 affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.
The European Commission's (EC) White Paper of 2001 on a ‘future chemical strategy’ proposed a system that requires chemicals manufactured in quantities of greater than 1 tonne to be ‘registered’, those manufactured in quantities greater than 100 tonnes to be ‘evaluated’, and certain substances of high concern (for example carcinogenic, mutagenic and toxic to reproduction - CMR's) to be ‘authorised’.
The EC adopted its proposal for a new scheme to manage the manufacture, importation and supply of chemicals in Europe on in October 2003. This proposal eventually became law once the European Parliament officially approved its final text of REACH. It came into force on 1 June 2007.
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.
A requirement is to collect, collate and submit data to the European Chemicals Agency (ECHA) on the hazardous properties of all substances (except Polymers and non-isolated intermediates) manufactured or imported into the EU in quantities above 1 tonne per year. Certain substances of high concern, such as carcinogenic, mutagenic and reproductive toxic substances (CMRs) will have to be authorised.
Chemicals will be registered in three phases according to the tonnage of the substance evaluation:
More than 1000 tonnes a year, or substances of highest concern, must be registered in the first 3 years;
100-1000 tonnes a year must be registered in the first 6 years;
1-100 tonnes a year must be registered in the first 11 years.
In addition, industry should prepare risk assessments and provide controls measures for using the substance safely to downstream users.
Evaluation provides a means for the authorities to require registrants, and in very limited cases downstream users, to provide further information.
There are two types of evaluation: dossier evaluation and substance evaluation:
Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are avoided, and to check the compliance of registration dossier with the registration requirements. Chemical companies failed to provide "important safety information" in nearly three quarters (74% or 211 of 286) of cases checked by authorities, according to the European Chemicals Agency's 2018 annual progress report. “The numbers show a similar picture to previous years," it said. Industry group Cefic acknowledged the problem.
Substance evaluation is performed by the relevant authorities when there is a reason to suspect that a substance presents a risk to human health or the environment (e.g. because of its structural similarity to another substance). Therefore, all registration dossiers submitted for a substance are examined together and any other available information is taken into account.
Substance evaluation is carried out under a programme known as the Community Rolling Action Plan (CoRAP). An independent review of progress by national officials published in late 2018 found that 352 substances have so far been prioritised for substance evaluation with 94 completed. For almost half the 94, officials concluded that existing commercial use of the substance is unsafe for human health and/or the environment. Risk management has been initiated for twelve substances since REACH came into force. For 74% of substances (34 out of 46), concerns were demonstrated, but no actual regulatory follow-up has yet been initiated. In addition, national officials concluded that 64% of the substances under evaluation (126 out of 196) lacked the information needed to demonstrate the safety of the chemicals marketed in Europe due to inadequate industry data.
REACH allows restricted substances of very high concern to continue being used, subject to authorisation.
This authorisation requirement attempts to ensure that risks from the use of such substances are either adequately controlled or justified by socio-economic grounds, having taken into account the available information on alternative substances or processes.
The Regulation enables restrictions of use to be introduced across the European Community where this is shown to be necessary. Member States or the Commission may prepare such proposals.
By March 2019, authorisation had been granted 185 times, with no eligible request ever having been rejected. NGOs have complained that authorisations have been granted despite safer alternatives existing and that this was hindering substitution. In March 2019, the European Court of Justice revoked an authorisation in a ruling that criticised the European Chemicals Agency for failing to identify a safer alternative.
Manufactures and/or importers should develop risk reduction measures for all known uses of the chemical including downstream uses. Downstream users such as plastic pipe producers should provide detail of their uses to their suppliers. In cases where downstream users decide not to disclose this information, they need to have their own CSR.