THE FUTURE IS “REACH”

In response to criticism of the ineffective current legislative system, the European Commission published its proposal for a Regulation in October 2003, after extensive stakeholder consultation. This Regulation would be directly applicable in Member States. This proposed new regime involves processes of Registration, Evaluation and Authorisation of Chemicals, known by the acronym REACH.  The new strategy extends far beyond the existing legislation it is intended to replace.
REACH will include requirements to register all chemicals on a phased prioritised basis and within certain quantity thresholds. Certain high-risk chemicals can be required to be authorised before they are manufactured or used. Any chemicals registered, and particularly chemicals presenting risks, may be required to be evaluated and their manufacture or use can be subject to restrictions. All chemicals must be classified and labelled.
REACH has the following objectives:
Protection of human health and the environment
Maintenance and enhancement of the competitiveness of the EU chemical industry
Prevention of fragmentation of the Internal Market
Increased transparency
Integration with international aspects
Promotion of non-animal testing
Conformity with EU international obligations under the WTO.
This new strategy was initiated by DG Environment but is now being progressed jointly with DG Enterprise. In October 2003 the European Council decided that the Competitiveness Council should have the lead responsibility to examine this proposal, in co-ordination with other Council formations. Strong commitment to the effective enactment of the measure has been given by Government leaders at European Councils and also at Competitiveness and Environment Councils. 
The full Regulation, background information, Question & Answer Documents and other useful papers can be found on the EU website :
http://europa.eu.int/comm/enterprise/reach/index_en.htm
Negotiations at a European level are ongoing in a joint Council Working Group, especially created and reporting to both the Competitiveness and Environment Councils. Even though these negotiations are complex and there is no political agreement yet on any of the 14 Titles of this 1,200 page proposal, there is broad support for the aims of REACH among all Member States and a significant momentum has developed to advance the negotiations quickly.

Classification and labelling of dangerous substances and preparations
All dangerous substances and preparations placed on the market are subject to classification and labelling requirements.
The REACH proposal does not at present include rules for classification, labelling and packaging of dangerous substances, therefore the relevant parts of Directive 67/548/EEC will continue to apply. Directive 1999/45/EC will also continue to apply for the classification, packaging and labelling of dangerous preparations.
The object of classification is to identify all the physicochemical, toxicological and ecotoxicological properties of substances and preparations which may constitute a risk during normal handling or use.
The most severe hazards are highlighted by symbols, such hazards and those arising from other dangerous properties are specified in standard risk phrases, and safety phrases give advice on necessary precautions.
The label draws the attention of persons handling or using substances and preparations to the inherent danger of certain such materials.
Classification and labelling inventory
In the framework of REACH, a classification and labelling inventory shall be established and maintained by the Agency in the form of a database. It will be widely available as a source of information on substances.
Industry will be required to include all its classifications on the inventory. Any divergences between classifications of the same substance should be removed over time either through co-operation between notifiers and registrants or by EU harmonisation. EU harmonised classifications (Annex I of Directive 67/548/EEC) will only be required for the following properties: substances that are category 1, 2, and 3 carcinogens, mutagens or toxic to the reproductive system; or respiratory sensitisers.
A downstream user may, through conducting a chemical safety assessment or otherwise, conclude that the classification and labelling for a substance are different to that given to him by his supplier. This fact must be reported to the Agency.Downstream users do not have to report if they are using a substance in quantities of less than 1 tonne.
Globally harmonised system on the classification and labelling of chemicals (GHS)
As a result of the Rio declaration on Environment and Sustainable Development in 1991, a globally harmonised system on the classification and labelling of chemicals (GHS) has been developed and was adopted in July 2003 by the UN Economic and Social Council.
The European Commission, the majority of the Member States as well as many of the new Member States have actively taken part in the work to elaborate GHS.
The Commission will come forward with the necessary proposals for having it adopted at the same time as the final adoption of the REACH legislation.

The safety data sheet (SDS)
The information through the supply chain provisions ensure that all users of substances have the information they need to use them safely.
The primary tool for information transfer is the safety data sheet.

The safety data sheets enable:

• the employer to determine whether any hazardous chemical agents are present in the workplace, and to assess any risk to the health and safety of workers arising from their use;
• users to take the necessary measures relating to protection of health and safety at the workplace.

Making SDS available to workers and their representatives is consistent with the Globally harmonised system on the classification and labelling of chemicals (GHS).
The REACH regulation will replace the current Safety Data Sheets Directive.
The current duties and responsibilities for SDS remain and will be extended by the requirement to convey information from any chemical safety assessment.
For instance, where a chemical safety assessment is performed (substances placed on the market in quantities ≥ 10 tonnes per year by a manufacturer or importer), the relevant exposure scenarios (main elements of the “exposure” part of the chemical safety report) shall be placed in an annex to the safety data sheet.
The exposure scenarios contain a description of the risk management measures which the manufacturer or importer has implemented and recommends to be implemented by downstream users.