Brief Overview

A lengthy process of analysis and discussion finally culminated in the adoption of the REACH Regulation. Unlike earlier policy, the new regulation requires manufacturers and importers to gather information on their substances and register the information in a central database, and aims to improve health and environmental protection through the better identification of the properties of chemical substances, and the gradual elimination of very dangerous chemicals from use.

See the European Commission’s “REACH in Brief”, published in October 2007. This covers why we need REACH, how REACH works, what the benefits and the costs are; what the decision-making process was; and how REACH will be implemented.

See also “Navigating REACH” co-authored by 7 NGOs who worked on REACH, published in August 2007.

1. The basic elements of REACH
2. Candidate List
3. REACH Implementation Timeline
4. What does REACH apply to?

The basic elements of REACH

Registration: Under REACH each producer and importer of chemicals in volumes of 1 tonne or more per year and per producer/importer – around 30,000 substances - will have to register them with a new European Chemicals Agency in Helsinki (ECHA). Manufacturers and importers will be required to gather information on the properties of chemical substances, which will allow their safe handling and register the information in a central database.

The European Chemicals Agency will co-ordinate this process and run the public database that will enable consumers and professionals to find hazard information. All non-confidential information will be made openly available to the public. Producers and importers will be able to use existing data on chemicals and share information, and will be required to pass safety information onto “downstream users”. Failure to register will mean that substance will be prohibited from being manufactured in, or imported into, the EU.

Evaluation: There are two types of evaluation. The first is “dossier evaluation” whereby public authorities will examine registration dossiers, requesting more information if necessary, and the second is “substance evaluation”. There will be measures to limit animal testing to the absolute minimum (reviews of animal testing proposals; compulsory data sharing from animal tests; and prescription of alternative methods wherever possible).

Authorisation: In order to deal with chemicals of high concern, REACH foresees a special permission system. “Substances of very high concern” are those that can cause cancer, mutations or problems with reproduction (CMRs), or that accumulate in human bodies and the environment (Persistent, Bioaccumulative and Toxic – PBTs; very Persistent and very Bioaccumulative – vPvBs), and other chemicals which are of ‘equivalent concern’. These substances will have to obtain authorisation which is specific to a particular use or ‘application’ . Also, within this group of substances, some will be subject to stricter conditions in order to obtain an authorisation – the persistent and bioaccumulative chemicals can only get an authorisation if the socio-economic benefits outweight the risks of use, and if there are no safer alternatives.

Restriction: REACH will also have a restriction procedure, where the manufacture, placing on the market and use of certain dangerous substances is regulated separately from the ‘authorisation’ procedure. The restriction provision introduces a safety net, together with a clearer and faster decision-making mechanism.

Candidate List

Over the next decade, thousands of chemicals will be registered, some of them will be further evaluated, and some chemicals will have to be replaced by safer alternatives. The most harmful chemicals, called “substances of very high concern”, will be put on a “Candidate List” for authorisation.

The first edition of the Candidate List was published in October 2008. Consumers now have the right to be informed by manufacturers whether any product produced in Europe contains any of the substances on the list.

REACH Implementation Timeline

1 June 2007: REACH entry into force

1 June 2008: Start of registration for new (post 1981) substances, which have to be registered before they are placed on the EU market whether manufactured in the EU or imported.
Autumn 2008: Publication of the “List of ‘candidate’ substances” – all chemicals ‘of very high concern’ (see above), whose properties make them eligible for the Authorisation process.

From 1 June 2008 to 1 December 2008: Pre-registration of existing (pre 1981) substances will take place. Pre-registration allows companies to get in touch with other companies intending to register the same substance and enables them to set-up a ’Substance Information Exchange Forums’ (SIEF). In a SIEF, companies are obliged to share animal testing studies to keep the number of animals used for testing to an absolute minimum. They may also share other data voluntarily.

By 1 December 2010: The following will have to be registered with the European Chemicals Agency:

 All substances produced or imported in quantities equal to or greater than 1000 tonnes/year;

 Carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) equal to or greater than 1 tonne/year and

 Substances classified as very toxic to aquatic organisms (R50/53) at and above 100 tonnes/year;.

From 1 June 2011: Substances in articles (products) which are on the “candidate list” (subject to certain criteria) will need to be reported to the European Chemicals Agency.

By 1 June 2013: All substances produced or imported in quantities equal to, or greater than 100 tonnes/year have to be registered.

By 1 June 2018: All substances produced or imported in quantities equal to or greater than 1 tonne/year have to be registered. Manufacturers and importers who have not registered their chemicals properly will no longer be able to place them on the EU market.

What does REACH apply to?

Some European legislation that regulates chemicals has not been folded into REACH. Pesticides, for example, are still under separate legislation. Moreover, REACH only covers some chemicals: of the approximately 100 000 chemicals on the European market, REACH applies to 30 000 which are manufactured or imported into the EU, whether used as ‘intermediates’ (in making other chemicals) or on their own, in preparations (such as paints) or consumer products (textiles dyed with chemicals, or furniture). Some parts of the REACH Regulation apply to chemicals used above 1 tonne per year (per manufacturer or importer); other parts apply to chemicals which are not registered, or which are produced/imported below 1 tonne per year.

There are some exemptions:

• Radioactive substances
• Substances under customs provision
• Transport of substances
• Non-isolated intermediates
• Waste
• Polymers (eg PVC plastics) exempted for the time being

Substances used for research and development are subject to special rules, whilst a number of other substances are exempted from parts or all of REACH where other legislation applies:

• Pesticides + biocides
• Cosmetics (exempted from certain requirements
• Substances in food and medicinal products and medical devices