General Assembly Meeting Thursday, May 5th 10:00 – 13:00

General Assembly Meeting - 2022

Highlights from the General Assembly Meeting
 

The 2022 General Assembly meeting which took place virtually on May 5th discussed general issues related to the smooth running of the consortium as well as possible threats emanating from ECHA/the Commission by way of potential Restrictions/Authorisation related to the use of several Mn substances within the EU amongst other things.

The meeting saw the following decisions taken

The GA agreed a on methodology to redistribute income from Non-EU REACH data sales. MARA’s assets in the form of study reports are being sold for the purposes of Non-EU regulatory compliance in the hope of sharing knowledge on the toxicity profile of Mn-based substances in view of a worldwide harmonising the classification. The GA agreed that if the entire industry use the same data – then industry will settle for the same classification.
 

MARA’s Office: The GA discussed the need of an actual office versus a virtual office from a financial standpoint. Considering that work was still effective during the pandemic lockdown, it was clear that a virtual office will reduce cost without affecting the quality of work carried out by the Consortium. To this end, the GA approved for MARA to seek advice from the French authorities on the possibility of a Not-for-profit organisation to be domicile virtually.
 

Harmonised Categorization of Slags across the EU: The GA approved a way to fund this special project. The project which considers the present regulatory constraints on the use or disposal of slags across the EU to be non-harmonised is aimed at creating a level playing field guided by a harmonised regulatory standpoint for all players within the EU. The project intends to use a robust socio-economic analysis and lobbying of the authorities to achieve its goes.

New Classification for FeMn slag - Update your SDS’s

A final decision from ECHA to conduct a Prenatal developmental study on a second specie  (Rabbit, OECD 414) and submit a registration update by June 4th 2020, prompted further investigations related to developmental toxicity for this UVCB substance. After evaluating this parameter with data - as per below, it is clear that FeMn slag will be classified as a developmental toxicant - Catergory 2 - H361d. Therefore, please update your eSDS's accordingly.

Data:

1) Ferromanganese Slag: Study for Effects on Embryo-Fetal Development in the Rat by Oral Gavage Administration/OECD 414/Envigo Labs

2) Ferromanganese Slag: Study for Effects on Embryo-Fetal Development in the Rabbit by Oral Gavage Administration/OECD 414/Envigo Labs

Evaluation of Data

The  guideline and GLP compliant prenatal development toxicity study in RATS  identified no effects of FeMn slag on the pregnancy or on survival or development of foetuses after dosing up to the limit dose of 1000 mg/kg/day.

Contrary to the rat,  in the rabbit prenatal development study, adverse foetal effects were observed at all dose levels (100, 300 or 800 mg/kg/day), with minor skeletal ossification delays also apparent at 300 or 800 mg/kg/day.  In view of the nature and incidence of major fetal abnormalities detected in all treated groups, a NOAEL for embryo-fetal development was not established. 

In the absence of clear evidence of an adverse effect on development to warrant Category 1b, it is considered plausible to consider a classification of Category 2 (H361) for developmental toxicity. Moreso,  with adverse effects only observed in one species with confounding vehicle effects and no maternal or developmental effects of prenatal exposure to FeMn slag in the other species, this proposed classifcation is considered by the Mn Consortium as adequate, although the regulators could argue otherwise. 

For more information contact: reach@manganese.org

 

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