Is your next regulatory deadline within REACH?
The REACH 2018 deadline applies to substances manufactured or imported into Europe in volumes of between 1 and 100 tonnes per annum. Many companies are still unaware of the workload and challenges they face in preparing dossiers for substances in time to meet the registration deadline in 2018. ECHA registration Directorate estimate that the Agency expects to receive more than three times as many registration dossiers as under the previous deadline in 2010 and 2013. It is expected that over 70,000 registrations covering approximately 30,000 substances will be prepared. It is anticipated that there will be a significant increase in demand for testing and analytical laboratories for the placement of work.
Smithers Viscient serves a global client base and has all the required official accreditations necessary to provide regulatory studies to support product registrations in full compliance with Good Laboratory Practice Regulations. Our scientists are experts in the design and implementation of experimental protocols offering a wide variety of analytical services in physical and chemical properties, ecotoxicology and environmental fate using state of the art analytical instrumentation. We provide superior quality and value through expert advice, accurate and timely delivery and clear, concise communication.
Since only substances are registered under REACH, correct and unambiguous substance identification is essential. REACH Environmental data requirements (Annex VII – VIII) include data on physical-chemical properties, ecotoxicological information and environmental fate properties.
Substance Identification and Characterisation
It is the responsibility of registrants to provide sufficient spectral data to confirm the structure of their substance and to use suitable chromatographic methods to verify the composition. At Smithers Viscient we employ state of the art spectroscopic and chromatographic techniques to define the identity of a substance and characterise the overall composition. Our substance identification and characterisation service employ the following techniques for analytical characterisation:
- Spectroscopic techniques (UV-VIS, IR, FT-IR, NMR*, XRD*ICP-OES/MS*, LC-MS, GC-MS)
- Chromatographic techniques (HPLC, LC, GC,)
Our analytical experts follow a cost effective approach to substance identification and characterisation and will only apply the spectroscopic and chromatographic techniques that are scientifically meaningful and practically possible. Our state-of-the-art equipment ensures that we provide excellent quality spectra and chromatograms that are fully interpreted. In situations where tests are not deemed to be necessary or appropriate, we provide the appropriate scientific justification.
Testing for physico-chemical properties forms the central part of the data package for REACH registrations. A good understanding of the physico-chemical properties is vital in designing the appropriate environmental fate and ecotoxicological data packages. Smithers Viscient performs physical chemistry testing according to REACH Annex VII-VIII and OECD Guidelines. Our physical chemists work in close collaboration with a team of method developers to obtain consistent, reliable and accurate data. We apply standard OECD Test Guidelines for well-defined substances:
- Melting Temperature/Freezing Temperature – OECD 102/EU A1
- Boiling Temperature – OECD 103/EU A2
- Relative Density – OECD 109/EU A3
- Vapour Pressure – OECD 104/EU A4
- Surface Tension – OECD 115/EU A5
- Water Solubility – OECD 105/EU A6
- Partition Coefficient (HPLC) – OECD 117/EU A8
- Partition Coefficient (Shake Flask) – OECD 107/EU A8
- Partition Coefficient (Slow Stir) – OECD 123
- Flash point (Liquid only) – EU A9
- Flammability (Solid) – EU A10
- Flammability (Contact with Water) - EU A12
- Pyrophoric Properties of Solids and Liquids - EU A13
- Explosive Properties (Liquid) – EU A14*
- Explosive Properties (Solid) – EU A14*
- Auto-ignition Temperature (Liquid) – EU A15
- Relative Self-ignition Temperature (Solid) – EU A16
- Oxidising Properties (Solid) – EU A17
- Oxidising Properties (Liquid) – EU A21*
- Stability in organic solvent
- Dissociation constant
- Viscosity – OECD 110
- Granulometry – OECD 111
We are also experienced in working with substances WHICH have properties that complicate the testing and exposure assessment. These so called challenging substances include:
- Poorly water soluble substances
- Unstable and reactive substances
- Surface active substances
- Substances with sorptive properties
- Complex mixtures
- Naturally occurring substances with Unknown or Variable composition, Complex reaction products or Biological materials (UVCB’s substances)
REACH testing scheme:
In order to assist our clients with their planning we have produced an example REACH Annex VII Schedule of Studies highlighting the number of weeks it takes to conduct tests per study type to meet the full Annex VII requirements.
QA approved drafts are provided
Link to REACH infographic
Link to REACH datasheet
Smithers Viscient undertakes Physical Chemistry tests according to the OECD and corresponding EU guidelines and can also perform a limited number of tests as required under UN GHS (as implemented in the CLP regulations) “ Recommendations on the Transport of dangerous Goods manual of Tests and Criteria” regulations dependent upon the substance.