Registration, Evaluation, Authorisation and Restriction of Chemicals

Regulation (EC) No 1907/2006

European Union regulation
Title	Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (ECHA)
Made by	European Parliament and Council
Made under	Art. 95 (EC)
Journal reference	L396, 30.12.2006, pp. 1–849
History
Date made	18 December 2006
Entry 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
Current legislation

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.

Overview

European Chemicals Agency headquarters in Annankatu, Helsinki.

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.

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 15 June 2015, there are 168 SVHCs on the candidate list for authorization.

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 that 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) that simplifies capturing, managing, and submitting 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.

The aim of REACH is to improve the protection of human health and the environment by identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced.

Background

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.

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.

Registration

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:

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

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.

The relevant authorities perform substance evaluation 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.

Authorisation

Main article: REACH authorisation procedure

The REACH proposal sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorisation requirement.

This authorisation requirement ensures 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.

Information exchange

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.

REACh Key Dates

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. 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 particles 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 VI 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.

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). 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 now required but allowed only once per each new 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. 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.

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.

Only representative services

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.

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").

Example of chemical inventories in various countries/regions

Source:

• 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
• Giftliste 1 (Swiss list of toxic substances, repealed in 2005)

Authorisation List

The European Chemical Agency (ECHA) has published the REACH Authorisation List, in an effort to tighten the use of Substances of Very High Concern (SVHCs). The list is an official recommendation from the ECHA to the European Commission. The list is also regularly updated and expanded. Currently the Candidate List for Authorisation comprises a total of 173 SVHCs, some of which are already active on the Authorization List.

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 processed.

See also

• Toxic Substances Control Act of 1976 - US law
• Kashinhou - Japanese law
• Consumer protection
• Environmental health
• International Material Data System
• Pesticides in the European Union
• Porter hypothesis
• Quality of life

External links

• European Chemicals Agency - The organization responsible for implementing REACH

• "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)
• Global Chemical Inventories
• REACH resources and tools - Institute of Occupational Medicine fact sheets
• REACH and nanomaterials