REACH Annex II Compliance Statement
As a customer of ROCOL, you may be aware that REACH Annex II of regulation 453/2010 is to be enforced for all products that are classed as mixtures. The deadline for the application of Annex II to regulation 453/2010 is the 30/11/2012.
From 01/12/2012, all Material Safety Data Sheets produced by ROCOL will conform to the new regulation.
The Material Safety Datasheets are available from our website:
From customer services
0113 232 2700
ROCOL cannot supply Material Safety Data Sheets with non ROCOL filenames.
- stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals
- is the new chemicals regulation within the European Union
- came into force on June 1, 2007
The idea behind the new regulation on chemical substances is to ensure a high degree of protection for health and the environment. REACH places the responsibility for the safety of chemicals with the chemical industry. It is for the industry to ensure that all substances are tested (depending on the quantity in which they are produced or imported) and that safety data regarding their uses is available.
Substances must be registered with the European Chemicals Agency (ECHA, Helsinki) by submitting a registration dossier. All products in the supply chain, from the manufacturer (or importer) to the downstream user, are affected by REACH.
What is affected?
All substances produced in or imported into the European Union are subject to the REACH regulation. Any substance produced or imported in a quantity exceeding 1 metric ton per annum (t pa) must be registered. Existing substances can receive phasein status; this means immediate registration is not necessary (and can occur during a transition period dependant on tonnage). However, transition periods are available only for those substances that have been pre registered.
Pre-registration requires submission of only a few details such as substance name, CAS and EINECS numbers, name and address of the registrant (legal entity), the tonnage band, and the projected registration deadline. The deadline for Pre-registration was November 30 2008.
Registration requires the submission of a technical dossier to ECHA, the content of which is determined by the tonnage band that the substance falls into. For existing substances (phase-in substances) in the tonnage band 1 – 10 t pa, physical and chemical data is required (specified in Annex VII of the regulation) as well as available data on toxicology and ecotoxicology.
For substances in quantities > 10 t pa, additional tests are required (specified in Annex VIII). In addition to an extended safety data sheet (eSDS), a chemical safety report (CSR) must also be prepared.
For substances in quantities greater than > 100 t pa, additional requirements regarding possible risks to health and the environment must be fulfilled. Further test proposals must be submitted to ECHA.
Evaluation and Authorisation
The Agency checks the submitted documents for completeness, and decides whether additional tests are necessary (dossier evaluation). In cases of substances giving particular cause for concern, an authorization and restriction process may be required.
- Nov. 30 2008: Pre-registration deadline for all substances
- Dec. 1 2010: Registration deadline for substances >1000 t pa, R50/R53 substances >100 t pa, CMR substances of categories 1 and 2 >1 t pa
- June 1 2013: Registration deadline for substances 100–1000 t pa
- June 1 2018: Registration deadline for substances 1–100 t pa
How will you be affected by REACH?
Manufacturers or importers must ensure that all substances and components of preparations (whether produced or imported) in quantities >1 t pa are registered according to REACH requirements. For substances >10 t pa they must prepare a chemical safety report containing, in addition to all uses of which they are aware (identified use), detailed data on exposure, risk management measures, and risk characterisation. Information from this chemical safety report will be made available to downstream users in compact form as an extended safety data sheet (eSDS).
As a downstream user, you must inform the manufacturer or importer about all uses of a substance. It might be the case that some of the uses of a substance cannot be supported by the manufacturer. For those uses that are not covered by the manufacturer’s chemical safety report you must prepare your own chemical safety report or stop using the substance.
How is ROCOL implementing REACH?
ROCOL is committed to meeting its obligations under the REACH regulations and has undertaken intensive preparations for implementation. We are aware of the widespread concerns regarding product continuity and are spending a great deal of time talking to customers and suppliers about collaborating with them to clarify product status and to fill in any information gaps that may exist.
What is the Current Status of REACH at ROCOL?
ROCOL has complied with the requirements for pre-registration, ensuring that all substances manufactured on site or imported into the EU were pre-registered by the deadline of 30 November 2008.
Manufactured volumes dictate that full registration of these substances is not obligatory until 1 June 2018. However, ROCOL is actively involved with the European Reach Grease Thickeners Consortium in working towards early full registration of the grease thickeners. Other substances will follow, using this model to ensure all registration requirements are met by 1 June 2018.
ROCOL is continually reviewing all products for the presence of SVHCs (Substances of very High Concern). This is a list of particularly hazardous substances which require special consideration and authorisation under REACh. All ROCOL products are free from substances on the current list of SVHCs. Monitoring will continue as the list is modified and extended.
ROCOL is also communicating with suppliers and customers to provide information on uses of chemicals in accordance with the Use Descriptor System devised by ECHA. This will enable our suppliers (and subsequently ourselves) to ensure that all product uses are taken into account when preparing a Chemical Safety Assessment which is required to complete full registration.
Does ROCOL intend to discontinue any products as a result of REACH?
At this time, we are not aware of any products supplied from the ROCOL manufacturing facilities in the UK that will be withdrawn due to the requirements of REACH.
Further information about REACH?
You‘ll find a lot of information and more help on the Internet:
- HSE – http://www.hse.gov.uk/reach/index.htm
- REACH Ready – http://www.reachready.co.uk
- European Chemicals Agency – http://echa.europa.eu/home_en.asp