Why can the determination of the Particle Size Distribution (PSD) be challenging?
The PSD is required for a number of regulatory purposes:
granulometry for the REACH dossier of solid substances (OECD 110)
REACH substance identity profile (sameness) for Nanomaterials
the definition of nanoforms
analytical determination of nano materials in genotoxicity or ecotoxicological studies
The smaller the particles are, the more elaborate the techniques have to be. LAUS has equipped a new lab with state-of-the-art technology and trained a highly qualified study director. We have developed a deeper understanding on how to approach the different substance types (e. g. nanomaterials) and how to receive comprehensive results. Sometimes complementary techniques like SEM/TEM, XRD with Rietveld or BET are required to describe a substance in its entity.
For Plastic Food Contact Materials EFSA requires genotoxicity testing including a minimum of two in vitro studies:
i) A bacterial reverse mutation test
ii) An in vitro mammalian cell micronucleus test
In a first step the specific migration limits (SML) expressed in mg of substance per kg of food (mg/kg) needs to be determined for the packaging material. If the exposure through migration is low, this limited data set might be sufficient. If the exposure is higher, a strategy with more toxicological information will be required.
A NRES is a new registrant of a substance that was previously registered under EU REACH before 1 January 2021 by any legal entity.
First step in the process is to submit an Article 26 inquiry according to UK REACH. When the NRES status has been confirmed, 2, 4 or 6 years plus 300 days from the end of the transition period (i.e. from 31 December 2020) remain for the submission of the full information requirements.
If you are a non-GB based manufacturer or formulator your OR must submit analytical data generated from a sample manufactured by you or your non-GB based manufacturer for an Article 26 inquiry under UK REACH:
An inquiry dossier should contain information:
- about the potential registrant
- about the identity of the inquired substance
- where the potential registrant would need to carry out new studies, including those involving vertebrate animals.
LAUS can support you with both, the OR service and the generation of the analytical data for the substance identity.
First step of any new registration under UK REACH is to submit an Article 26 inquiry. There are two more szenarios where you should submit an Article 26 inquiry to HSE:
- You have completed the DUIN and would like to start with the data sharing process.
- DUIN is not possible since you do not fulfill prerequisites.
After the inquiry you will receive your inquiry number and become part of a substance group - a group of potential co-registrants of the same substance (formerly known as SIEF under EU REACH). This will enable you to engage in the data sharing process for a successful registration within the applicable timeframe. Questions? Click here or contact us!
On May 19, 2022, the “Firmenlauf Südpfalz” finally took place as a live event after two virtual runs.
3,012 participants from 164 companies completed the 5 km course and were happy about their sporting successes or simply about the community experience, which had not been possible for so long. LAUS had 9 participants running. Congratulations to everyone!
The use of NAMs (New Approach Methodology / non-animal alternative methods) is requested for the safety assessment of cosmetic ingredients and cosmetic products wherever possible. For eye/skin and mutagenicity evaluation LAUS offers the following ECVAM validated methods:
LAUS is the leading GLP lab for the determination of the Vapour Pressure using the Effusion Method (Knudsen Cell) according to OECD 104 / EU A.4. We are able to measure vapour pressures as low as 10E-12 Pa.
This method is based on the estimation of the mass of test substance flowing out per unit of time of a Knudsen cell under ultra-vacuum conditions. The mass of effused vapour is then being obtained by weighing the cell. Data are being collected between 30 – 150 °C, values for 20 and 25 °C are being calculated.
By operating two custom produced measuring apparatuses in parallel we have very high capacities and minimum delays. With more than 20 years of experience, we offer our advice even for difficult substances.
The Vapour Pressure is a key physico-chemical parameter for the assessment of a substance. It provides an indication of the evaporation rate and relates to the tendency of particles to escape from the liquid or solid phase. A substance with a high vapor pressure at room temperature is considered as volatile.
According to its “Progress in evaluation 2021” report ECHA performed 300 full compliance checks (CCHs) and 227 testing proposal examinations (TPEs) and issued 467 draft decisions: 280 on the abovementioned compliance checks and 187 on testing proposal examinations. That means 93% of dossiers require additional information.
Number of requests in 278 compliance check decisions:
Long-term aquatic toxicity 344
Physico-chemical properties 60
Number of requests in 165 testing proposal decisions 79/41/8
Long-term aquatic toxicity 41
Physico-chemical properties 8
LAUS has a great team with particular expertise in these areas and a lot of experience with difficult substances. If you are concerned and need additional data, don’t hesitate to contact us.
LAUS stands with all who are suffering as a result of the conflict in Ukraine.
In an effort to provide for the smallest and most vulnerable in this humanitarian catastrophe we send baby food to Ukraine. Thank you to Frank Hüsken for taking action and offering transport of donations in kind.