REACH - No Data No Market
On June 1, 2007 the new European chemicals legislation became effective:
The REACH regulation (Registration, Evaluation and Authorization of Chemicals, regulation (EG) No. 1907/2006) is the largest EU legislative process to date. It harmonizes the previous chemicals legislation. Its principle: no data - no market. This means that within the area of validity only those chemicals can be traded that have been registered. REACH is based on the principle of self-responsibility of the industry and generally applies to all chemical substances. Self-responsibilty also means, that manufacturers and importers are responsible for the security of their chemicals. It must be ensured, that all intended usage in the product chain is safe to handle, without being a danger to processors, consumers or the environment.
Up to 1981 there was no evaluation of chemicals within the EU. All chemicals which were registered on the EU market are now considered as so-called "existing substances". It is only since 1982 that new substances have had to be examined and described before they are marketed. Through the REACH directive in future adequate information about the effects of most existing substances on human health and the environment will be available.
The most important objectives of REACH are the improved protection of human health and the environment from the risks of chemical substances. Furthermore, the competitiveness of the European chemical industry should be reinforced / maintained. All chemical substances which are brought onto the market in the EU must be registered. For substances which are already on the market a transition period of up to eleven years can be claimed after preregistration. Without registration new substances in quantities exceeding 1 t/year must not be produced in the EU nor imported into the EU. This not only applies to single chemical substances, but rather also to substances in mixtures (formerly: preparations) and products. As a downstream user DAW also has obligations to be fulfilled under REACH which will in the coming years present us with substantial tasks and challenges, primarily:
- testing the safety of the application of substances in our products
- producing reasonable risk management measures
- communication of the risk management measures and imparting the safe application of our products to our customers
Article 33 of the REACH directive regulates the obligation for passing information to the consumer in the supply chain. This obligation to provide information arises when a substance in the list of candidates is contained in a product with more than 0.1 percent of the mass. For preparations the previously published communication continues via the safety data sheet. The consumer must be provided with the information needed for the safe use of the product, but must at least be informed of the name of the relevant substance. The respective information must be made available free of charge within 45 days of the customer's request.
DAW supports the objectives of REACH and is actively working on its implementation. We have made it our objective that REACH will have no negative effects on the properties or compositions of the products, so that they will also be available in the usual quality to our customers in the future. All products which we supply will, of course, also comply to all legal requirements in the future. At present no action for REACH is required on the part of our customers with regard to our products.
In co-operation with its suppliers, DAW has ensured that all substances included in our products have been preregistered. Furthermore, a new EDP tool is being used to implement the REACH Directive. All our products will also be supplied in the accustomed quality in the future and conform to all legal stipulations.
Currently, all manufacturers and importers must compile the appropriate registration dossiers for the substances which they want to register. The preregistration phase finished on 1st December 2008. During the registration of a substance all applications in the complete life cycle are recorded, together with the expected exposure scenarios and the corresponding risk management measures. After registration the substances must only be used according to the registered applications. If a downstream user finds that his application is not covered by the registration, he can request the manufacturer / importer to register this application retrospectively or initiate it himself. The descriptor model has been developed to simplify and standardise the communication within the supply chain. This system consists of the following five elements (descriptors):
- Field of application, industries (SU, sector of use)
- Product category (PC)
- Process category (PROC)
- Article category (AC)
- Environmental release category (ERC)
The categorised application information of the construction chemistry is available in the form of a standardised format - the so-called Use Reports (UseR). At DAW too, the descriptor model, the use reports of the Deutschen Bauchemie e.V. and the association of the German paints and printing inks industry (VdL) are employed. Based on the descriptor system and the use reports, DAW has carried out an initial mapping of the sales products. During the registration process the required information is available to confirm the described applications as safe.
The regulations about the "new" safety data sheets can be found in Article 31 in conjunction with Appendix II (Guideline for the production of the safety data sheet) of the REACH Directive. As a supplement to this, REACH guidelines for the production of the expanded safety data sheet have been elaborated. There is no transitional regulation for the implementation of the new safety data sheet requirements. Once registration has been concluded, additional information is included in the safety data sheet (e.g. the registration number); where necessary, an "expanded safety data sheet" is elaborated, to which relevant exposure scenarios are enclosed as an appendix. Our safety data sheets are updated once the appropriate information from the upstream suppliers is available.
According to the REACH Directive, DAW is a downstream user (natural or legal person, who uses a substance as such or in a mixture in the scope of its commercial / industrial activity). The products manufactured and sold by DAW are mainly mixtures of many substances. There is no registration obligation for these mixtures, but rather only for the individual constituents (substances). It is the objective of DAW to register all the substances contained in our products through the suppliers, i.e. the manufacturers and importers. With these registrations we will take into account the known applications of our customers.
Every six months the ECHA publishes an updated list of candidates with all the relevant substances.
The substance inventory is checked regularly based on the current list of candidates from ECHA.
The Directive (EC) 1272/2008 on the classification, labelling and packaging of substances and mixtures (GHS/CLP Directive), which came into force on 20th January 2009, replaces the previous title XI of the REACH Directive. All references in REACH have been changed appropriately. The GHS/CLP Directive transfers the Globally Harmonised System (GHS) of the UN to EU law.
REACH improves the data basis for the implementation of the GHS/CLP Directive, because information on the classification and labelling for the substances to be registered must also be conveyed. This information is stored in a newly created classification and labelling index which makes the currency and quality of self classifications more transparent. If a substance fulfils the legally defined hazard features, it must – as with mixtures – be appropriately classified and labelled.
Read more information about REACH