Assessment of Substances in Europe

 

The REACH System (Registration, Evaluation, Authorisation of Chemicals)
The draft legislation, which will replace over 40 existing directives and regulations, will implement the proposals set out in the Commission's February 2001 White Paper on the Strategy for a future Chemicals policy (see IP/01/201). At its core is REACH: a single, integrated system for the Registration, Evaluation, and Authorisation of CHemicals. REACH will place a duty on companies which produce, import and use chemicals to assess the risks arising from their use requiring new test data to be generated in justified cases - and to take the necessary measures to manage any risks they identify. This will reverse the burden of proof from public authorities to industry for putting safe chemicals on the market. Testing results have to be shared to reduce any likely animal testing. Registration of information on the properties, uses and safe use of chemical substances will be an integral part of the new system.


Scope of  REACH
The exact registration requirements will vary depending on the volume in which a substance is produced, and on the likelihood of exposure to humans or the environment. A phased-in system lasting up to 11 years is foreseen. Higher tonnage substances would require the most data, and would have to be registered first; lower tonnage substances would require less data and be registered later. The latter provisions will particularly reduce the regulatory burden on small and medium sized enterprises.
Tighter controls will be introduced for the chemicals of highest concern. Thus, certain types of substances s uch as carcinogens, mutagens and reproductive toxicants (CMRs), persistent, bioaccumulative and toxic substances (PBTs) and very persistent and very bioaccumulative substances (vPvBs) will be subjected to an authorisation regime and would be registered early. In certain cases also other substances, for example with endocrine disruption effects, could be included on a case by case basis within the authorisation system where it is shown that they give rise to the same level of concern.
Each use of such substances will have to be authorised for a specific use. Decisions would be based on a risk assessment and consideration of other socio-economic factors. Others, such as polymers (chemicals used as raw materials for plastics and detergents and a wide variety of other products), and substances used as intermediates (chemicals used to make other chemical substances or other products) will be subject to substantially lighter registration requirements. In many cases, where there is little risk of exposure, polymers and intermediates will be exempted from registration.

The text of the proposals may be found at:  REACH and REACH-Whitepaper
 

The Emission Scenario Documents published here are the result of Research made by the INFU for the Federal Environmantal Agency. We would like to express our thanks for the support given.

 

According to unified law, industrial chemicals in the European Union must be tested and declared before they can be offered on the market in defined amounts (Guideline 92/32/EWG of April 30th.1992 for the 7. change of the guideline 67/548/EWG; realized in German law in the new definition of the chemical substance law of july 25th.1994). Old substances which were available on the market before these declaration laws were passed are listed in the European List of old substances EINECS. Since the declaration law of the European Union was passed in 1993 (Declaration 793/93/EWG of march. 23th.1993 for the evaluation and control of environmental risks of old chemical substances), these old substances are also tested and evaluated according to a step by step process.

Within the European union, the risk evaluation (meaning the evaluation in a defined context) is done according to a defined process following Guideline 93/67/EWG for new substances and declaration 1488/94/EWG for old substances. The technical and scientific laws for the risk evaluation have been summarized in a compendium of laws in the English language, the so called Technical Guidance Document (TGD). The Federal Environmental Agency has performed important preliminary work for this document and provided qualified reasoning.

For the evaluation of the environmental exposition, substance specific concentrations (PEC-Values - Predicted Environmental Concentration) in the various environmental compartments (water, sediment, ground and air) are calculated. These PEC-Values are a basis for the risk evaluation of new and old substances during normal industrial use according to the chemical substance law and the old substance declaration of the EU.

Default emission factors are listed for almost all possible emission types in the appendix of the TGD, divided by industrial branch and use category. In addition to this, chapter 7 of the TGD contains so called "Emission Scenario Documents" for several industrial branches. These use a technology specific method to calculate the emissions for certain substances. Depending on the quality of the data and the plausibility, values provided by the industry may be substituted for the default values in the model calculations. This way specific, for example local data may be taken into account.