The new EU chemical legislation, REACH (Registration, Evaluation and Authorisation of Chemicals), applies to chemicals produced or imported above 1 tonne per year. The three main phases of the legislation process, the criteria for Substances of Very High Concern, and other aspects of the legislation, such as Restriction, are explained below.

Registration

Registration is the first phase of REACH legislation. This requires companies to provide specified health and safety information for all substances produced, imported or placed on the EU market (applies to volumes above one tonne per year) to the European Chemicals Agency (ECHA). This even includes chemicals introduced on the EU market prior to 1981. Manufacturers and importers of 10 tonnes or more per year of a substance must also submit a detailed chemical safety report (CSR). It must describe the risks for specified uses covering worker's-, consumer's- and environmental issues, including relevant exposure scenarios with appropriate risk management measures. Substances that are not registered within the given time limit cannot be produced or sold on the EU market. A pre-registration of substances was carried out during 2008 resulted in a list of some 140 000 substances.

Evaluation

The second phase of REACH is Evaluation. The European Chemicals Agency examines and evaluates the information submitted by producers and importers. The Agency determines whether further information on the substance must be supplied, and evaluates the testing proposals submitted by the registrant.

Authorisation

The final phase of REACH is Authorisation. If a chemical meets the criteria for Substances of Very High Concern as laid down in REACH, it cannot be produced or used unless Authorisation has been granted for a specific use. Authorisation is only given if the benefits of continued use of the substance outweigh the risks or if the potential risks are considered to be limited or "adequately controlled". If Authorisation is not granted, then the substance will not be allowed in the future. The responsibility for seeking Authorisation lies solely with the producer or importer of a substance. The time period for an Authorisation review is on a case-by-case basis - specific to each substance.

Authorisation is a long, time-consuming and costly process, since it includes a comprehensive investigation and requires thorough documentation of the chemical's hazards and risks to health and the environment. In addition, there are no guarantees that an Authorisation will be awarded - even after a company has invested huge amounts of resources and time to defend its use. Competitors and other third parties will be able to challenge any attempt to get a permit by presenting a solution that involves less dangerous substances. The EU is obligated by REACH to consider available information about alternatives when making judgements about granting Authorisation.

Substances of Very High Concern

REACH has brought about a unified system or criteria for determining which chemicals are hazardous. Authorisation is required these so-called Substances of Very High Concern (SVHCs), listed in the REACH Annex XIV, and they have at least one of the following characteristics:

• Carcinogenic, Mutagenic or Toxic for reproduction (CMRs) category 1 and 2
• Persistent, Bioaccumulative and Toxic (PBTs)
• very Persistent and very Bioaccumulative (vPvBs)
• give rise to an "Equivalent level of concern". These are chemicals that do not necessarily fall into any of the above categories, but have nonetheless proven to cause a similar level of harm to human health or the environment. Examples include hormone disrupting chemicals, so-called endocrine disruptors.
  Estimates suggest that there are about 2,000 known SVHCs currently in use in Europe. However, several of these substances, such as pesticides, are exempt from REACH since they are covered by other legislation or for other reasons. Therefore, the number of SVHCs that qualify for the Authorisation is actually lower.

The Candidate List

At the heart of the Authorisation process is a "Candidate list" of chemicals that meet the criteria for Substances of Very High Concern. Member states and EU authorities nominate dangerous chemicals to be included on this list, which is the first step on the long road to being included on the official Authorisation List. The first Candidate List, presented by ECHA on October 28, 2008, contains 15 chemicals. From this list, ECHA has chosen seven substances to be included on the so-called ECHA working list. These seven chemicals will be the first substances to reach the Authorisation phase of REACH.

The Right to Know

When a substance is listed on the Candidate List, it gives the consumer the Right to Know if that substance is present in a product. The producer/imported must be able to provide this information within 45 working days after a request by consumers. Downstream users (defined as recipients, including both downstream users in the supply chain and distributors/retailers of articles) will obtain the same information automatically.

The Candidate List triggers the flow of information about specific SVHCs on the list. This includes the mandatory passing on of information throughout the supply chain, notification that an SVHC is present in an imported product and providing information to consumers about the presence of SVHCs in consumer products.

Restriction

An alternative to Authorisation is Restriction. Under REACH, certain chemicals can be restricted, which means they cannot be manufactured or used unless they are specifically exempted. This applies to chemicals that represent unacceptable risks to human health or the environment. At present, these substances are listed in the Directive 76/769/EEG concerning restriction, but will be officially listed in the REACH Annex XVII when the Restriction part of REACH enters into force June 1, 2009. Restriction is the safety net of REACH, providing authorities with a tool to act quickly with high concern chemicals and uses.

Substitution plans

A Substitution plan shall be submitted by the applicant for Authorisation when the applicant identifies a safer alternative. Even if the agency committee identifies a suitable alternative via third party contributions, this information does not have to be taken into account for the adequate control route, but only at the review of the already granted Authorisation. If no alternatives have been identified, triggering a substitution plan, a research and development plan must be submitted with the application for Authorisation.

Substances in articles

If a product or article contains SVHC above 0,1% of the weight of the article, the manufacturer/importer must notify the European Chemicals Agency (ECHA). It is not clear whether the 0.1% limit applies to individual parts or the entire article. If the 0,1% limit applies to the entire article consumers or ECHA will probably not receive any information on SVHC content in imported articles such as toys, clothes, electronic equipment etc, since the total amount of a hazardous substance is probably less than the limit. According to practice from Restrictions, RoHS and ELV directives, such limits are applied to parts/materials/components.