The six-month long pre-registration period for chemical substances (chemicals) under the new European "REACH" law on chemicals (Regulation (EC) No. 1907/2006) begins on 1 June 2008.
Dr. Leirer, Technical Manager at OKS Spezialschmierstoffe GmbH, describes the company's position:
"OKS unreservedly supports the aims of REACH. We have actively supported the responsible treatment of chemicals and the environment for many years, working to ensure that our products are manufactured safely and that the manner in which these products are used by our customers does not present any risk.
OKS has carefully made all necessary preparations to meet the challenges of REACH. We are already in close contact with our suppliers and customers to ensure that we have all the information required for the registration and use of our products within the terms of REACH."
REACH Statement from OKS Spezialschmierstoffe GmbH
All manufacturers and importers of chemicals in quantities exceeding 1 tonne per year must now pre-register those chemicals with the new European Chemicals Agency in Helsinki before 1 December 2008. The Agency will subsequently evaluate the registration dossier that is submitted. Critical chemicals, such as carcinogenic, mutagenic and environmentally hazardous substances, will only be permitted (authorised) for a limited period, during which time they will be intensively assessed with regard to their hazardous properties and the safety measures that are in place.
What is REACH?
Following a preparatory phase lasting several years, REACH was adopted by the European Parliament in December 2006 and entered into force on 1 June 2007.
REACH stands for "Registration, Evaluation and Authorization of Chemicals", and applies to chemical substances that are to be placed on the market on their own, in preparations or in articles
What does REACH aim to achieve?
The goal of REACH is to ensure a high level of safety with regard to the handling and use of chemical substances through a single piece of European legislation on chemicals, in order to ensure the protection of human health and the environment.
REACH is based on the principle of individual responsibility. Accordingly, a manufacturer or importer may only market those chemical substances for which sufficiently good data is available (to allow registration) with regard to physical properties, toxicity, and environmental behaviour, and other relevant items.
The "no data, no market" principle means that non-registered chemicals can therefore not be marketed.
Which substances must be registered under the terms of REACH?
REACH applies to all chemical substances that are either produced in or imported into the EU in quantities greater than 1 tonne per year. Completely excluded from REACH are waste, non-isolated intermediates, radioactive substances and substances that are in transit through the EU. Substances exempted from registration include polymers, substances used in medicinal products for humans and animals, food for humans, feedingstuffs for animals, and active substances in plant protection and biocidal products, as these substances are already covered by existing EU legislation.
Who is affected by REACH?
REACH affects every legal entity established in the EU manufacturing or importing chemical substances and mixtures of substances, as well as downstream users who employ such chemicals or mixtures within the scope of their industrial or commercial business activities, e.g. for the formulation of chemical preparations. Private consumers are as such not affected by REACH.
What is the timeframe for REACH registration?
REACH enters into force
|01.06. - 01.12.2008||
Publication of pre-registered substances by the European Chemical Agency (ECHA) in Helsinki.
End of registration for chemicals > 1000 tonnes/year and environmentally hazardous (R50/R53) substances > 100 tonnes/year
Ende der Registrierung für Chemikalien > 100 t/Jahr
End of registration for chemicals > 1 tonne/year
What effects will REACH registration have on the marketing of "chemicals" over the coming years?
The REACH Regulation requires that all currently marketed chemicals (substances) that are to still be marketed after 1 December 2008 be pre-registered with the central European Chemical Agency (ECHA) based in Helsinki between 12 and 18 months after the act coming into force on 1 June 2007 (i.e. from June 2008 to November 2008). However, pre-registration only requires that the name and manufacturer of the substance be notified, so this process is relatively simple and incurs very little cost. It can therefore be anticipated that practically all substances currently on the market will be pre-registered by the manufacturers and importers, and will consequently remain available in the coming years. The list of pre-registered substances will be published in January 2009.
The pre-registered substances must then subsequently be registered within either 3, 5 or 11 years of the Regulation entering into force, depending on the quantity manufactured or imported. It is only this registration process that is associated with additional effort and costs. If the manufacturer/importer does not register within the appropriate period, then the substance must be withdrawn from the market. Most suppliers are currently not making any statements about whether they will register their substances, however it can generally be assumed that they will (with the exception of a few low-volume substances of little commercial value). We therefore do not expect that the end result will be a significant change in product availability.
What are the obligations on manufacturers and importers due to REACH?
1. Pre-registration with the ECHA in Helsinki of substances manufactured or imported in quantities of 1 tonne or more per year, within the period 01/06/2008 to 01/12/2008.
2. Registration of substances with a volume of > 1000 tonnes/year before 01/12/2010, with a volume of > 100 tonnes/year before 01/06/2013 and with a volume of > 1 tonne/year before 01/06/2018.
3. Identification of all uses of the chemical substance.
4. Production of exposure scenarios and recommendations for risk management in the use/application of the chemical substance.
5. Communication of the exposure scenarios along the supply chain by means of an extended safety data sheet.
What are the obligations on downstream users due to REACH?
1. Provision of information on the use of the substance to suppliers of the chemical substance.
2. Ensuring that the manner in which they themselves use the substance is covered by the supplier's exposure scenarios, and if not then production of their own chemical safety report.
3. Application of the operating conditions and risk-prevention measures specified by the supplier in the safety data sheet.
4. Production of an exposure scenario for their own chemical preparations (in their role as a formulator).
5. Communication of all exposure scenarios to customers by means of an extended safety data sheet.
The REACH Regulation also specifies modifications to the structure and content of safety data sheets, including the requirement to add an e-mail address in Section 1 and swap the order of Sections 2 and 3 (note: this requirement has already been implemented by OKS)
In accordance with Regulation (EC) No. 1907/2006, the content of safety data sheets must be updated once a relevant registration dossier is made available (not earlier that 2010); if necessary, the data sheets will then include a substance safety report (extended Safety Data Sheet, "eSDS").Back to overview