Is there an obligation to register metals?
Yes. Metals are “substances” according to REACH. Metals have been considered as chemical substances under EU legislation since 1967, and they are recognised as such internationally (e.g. under the UN Globally Harmonised System for Classification and Labelling). However, minerals and ores are exempt from Registration unless they are chemically modified.

 

Is there an obligation to register steel or other alloys?
Alloys are “preparations” under REACH, albeit special ones where the properties of the preparation do not always simply match the properties of the components. As preparations, alloys do not have to be registered but their component metals must be registered if manufactured/imported ≥1tonne. However, a CSR (Chemical Safety Report) need not be performed for a substance which is present in a preparation under the concentration limits referred to in part 14(2). If the CSR needs to be undertaken for the components, the way in which these components are bonded in the chemical matrix should be taken into account.
Note: the Commission, in close cooperation with industry, Member States and other relevant stakeholders, will develop guidance to fulfil the requirements under REACH related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations – such as metals incorporated into alloys. In doing so, the Commission will take full account of the work carried out within the framework of the REACH implementation projects (RIPs) and will include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be available before the entry into operation of the Regulation.

 

What is the purpose of pre-registration and registration? 
REACH requires manufacturers and importers of chemical substances (≥ 1 tonne/year) to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these can be used safely. Each manufacturer and importer must submit to the Agency a registration dossier documenting the data and assessments. 

All users of dangerous chemicals will be obliged to ensure the safe use of those chemicals through risk management measures identified in the registration dossiers and communicated to the users of chemicals through extended Safety Data Sheets.

Tens of thousands of companies across the EU are expected to be affected by the pre-registration and registration obligations. It has been estimated that over 180,000 pre-registration files will be submitted. They are expected to cover some 30,000 substances and 40,000 intermediates.  

The objective of pre-registration is to facilitate sharing of data between registrants, where possible, in order to reduce unnecessary testing, especially on vertebrate animals, and to decrease costs for the industry.

Companies are strongly encouraged to pre-register to benefit from the extended registration deadlines (2010, 2013 or 2018, see below). Pre-registration ensures that there will be no interruption in manufacturing, importing or supplying substances to users. Only limited information needs to be sent to the European Chemicals Agency and there is no pre-registration fee. 

 

What will happen to companies who do not pre-register a substance?
A company who has not pre-registered a phase-in substance must suspend manufacturing or importing it after 1 December 2008 until it has submitted a full registration dossier² for the substance to the European Chemicals Agency.

 

What are the obligationslinked to pre-registration? 
All companies that pre-register the same substance will become a member of a Substance Information Exchange Forum (SIEF) the aim of which is to avoid duplication on the testing of substances. In a SIEF, companies are obliged to share animal testing studies to keep these tests to an absolute minimum. They may also share other data.

 

Who should pre-register?
All EU-based companies that manufacture in, or import chemical substances into, the EU should pre-register if the quantities of the substance are one tonne or more per year.

EU-based producers or importers of articles should also pre-register those phase-in substances which are intentionally released from their articles, unless the substances were already registered for use in those articles.

Companies that manufacture substances, formulate preparations or produce articles outside the EU cannot (pre-)register substances. However, they can nominate an Only Representative, established within the EU to carry out the required (pre)registration of their substances which are imported into the EU. 

 

When can companies pre-register?
Pre-registration starts on 1 June 2008 and closes on 1 December 2008.

 

How can one find out what has already been pre-registered? 
The European Chemicals Agency will publish a list of pre-registered substances on its website by 1 January 2009. The published list will contain the names of substances, related identity codes and the first envisaged registration deadline. It will also include the names and other identifiers of related substances that pre-registrants have, but no information on the companies which have communicated them. 

 

What is the timeframe for the registration of pre-registered chemical substances?
The following extended registration deadlines apply to phase-in substances that have been pre-registered:

Until 30 November 2010 - 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 one tonne/year and substances classified as very toxic to aquatic organisms (R50/53) at and above 100 tonnes/year;

Until 31 May 2013 - substances produced or imported in quantities equal to or greater than 100 tonnes/year;

Until 31 May 2018 - substances produced or imported in quantities equal to or greater than one tonne/year.