After many years of discussion about evaluating the safety of existing chemicals, the EU Commission has at last crossed the last hurdles standing in the way of REACH implementation.
REACH will record around 30,000 commercially available substances. Approximately 1,500 chemicals of "very high concern" will be subject to an authorization process. The responsibility for REACH will be given to a new European Chemical Agency to be founded in Helsinki. The regulation should come into force in 2007.
REACH will have an effect on almost all producers, importers and downstream users of chemicals.
By reversing the burden of proof, this group will now have to declare that their substances, formulations and applications are safe. The REACH EU Regulation will have a direct effect. In many cases, after the regulation has been published in the Official Journal, little time will remain to process the required substance data and information and deliver the dossiers. National authorities will support this process with advice, reviews of the proposed testing strategies and random checks of the submitted dossiers.
All substances with a volume of >1 t/year per company must be registered. This quantity includes both imports and production.
Substance safety evaluations must be prepared for all hazardous substances from a volume of 1 t/year or other substances from >10 t/year.
Three years after REACH comes into force, several substance groups must be registered. These include substances >1000 t/year; CMRs from 1 t/year and environmentally hazardous substances from 100 t/year (approx. 1500 substances).
For substances >100 t/year the registration dossiers must be submitted at the latest 6 years after the regulation takes effect (approx. 10,000 substances).
For substances >1t/year the deadline is 11 years after REACH comes into force (approx. 20,000 substances).
After REACH takes effect, companies have one year before the 6-month pre-registration phase begins.
Data to be supplied
The REACH Regulation contains quantity-related and risk-related requirements for data and information. This data and information form the basis for assessing the risks and evaluating the substances. In addition to data and information about the properties of the substance the application categories are also important for the product safety assessment.
1. The requirements of the REACH Regulation are based on the volumes of substances a company imports and produces. In other words, there will be several companies with a different quantity structure for one and the same substance. All companies must register these substances according to the REACH Regulation.
2. There are quantity-related minimum requirements for the supply of data and information about the physicochemical properties, ecotoxicity and toxicity.
3. Generally, the material safety data sheets will have to be revised and the application categories added.
4. For substances >10t, safety evaluation reports have to be drafted in which the application categories must be mentioned.
5. Calculations/estimates in regard to water, air, soil and sediment exposure must be made.
Uncertainties in connection with REACH
1. Many of the substances will be produced and imported by several companies. Who is responsible for what and how will the strategies of the various players in the same market be reduced to a common denominator? The REACH Regulation envisages the formation of consortia but it will not enforce this.
2. Data protection; how is the data in my studies and the information about the applications protected? How long are my new studies protected?
3. Exposure scenarios for the application categories have not yet been defined; how reliable are the evaluations?
4. Information is also acceptable in place of specific studies. Many approaches for supplying information have not yet been tested adequately. In which cases can I evaluate substance groups? How can computer supported calculations of substance data (QSAR) prevent expenses for tests and what is cheaper and more reliable?
5. Will the evaluation approaches of REACH also stand up to the HQ requirements of OECD which come into force in 2008?
SGS carries out the necessary tests to characterise the chemicals and to determine the substance properties, the environmental behaviour, the degradability and ecotoxicity in accredited laboratories (DIN EN 17025). GLP requirements are established in our routines. SGS INSTITUT FRESENIUS in cooperation with Akademie Fresenius provides information about the latest developments in chemicals evaluation in regular trade conferences (www.akademie-fresenius.de).
We provide advice so that you can develop a cost-effective procedure that takes account of the available data and the findings to be derived from the data.
Our services include:
1. Reviewing the validity of the available data.
2. Compiling data and information about physicochemical parameters.
3. Compiling data and information about ecotoxicology.
4. Compiling data and information about environmental behaviour.
5. Compiling data and information about toxicology.
6. Compiling data and information about exposure scenarios.
7. Compiling material safety data sheets.
8. Developing exposure scenarios and exposure reports for the application categories.
SGS contact for the approval of chemicals/REACH
Contact our experts for the approval of chemicals/REACH.