The SEA has recently received the following information from the European Precious Metals Federation:
Recently, the European Chemicals Agency (ECHA) published the intention of Sweden to classify silver metal as:
Skin Sens. 1, H317
Muta. 2, H341
Repr. 1B, H360FD
Aquatic Acute 1, M-factor=10 (powder <1mm) and M-factor=1000 (powder <0.0001mm)
Aquatic Chronic 1, M-factor=10 (powder <1mm) and M-factor=100 (powder <0.0001mm)
This classification has been proposed in the context of the Biocidal Products Regulation but will apply to other regulations (e.g.: REACH) and other applications (e.g.: jewellery, electronics, solar energy etc.) as well. Skin sensitization cat 1 could trigger a restriction for skin contact materials like jewels. A classification as reprotoxicant category 1B can trigger a fast track restriction process banning all the consumer uses of silver and silver compounds (e.g.: no jewellery, no silverware anymore). This classification will also qualified these substances for the authorisation process under REACH which could require an authorisation for each industrial and professional use. The final aim of these regulatory measures is the substitution of the classified substances by safer alternatives.
A similar proposal has already been published for silver nitrate in December 2018 and is expected for silver chloride soon. Based on the read-across strategy supported by the REACH registration dossiers, these different proposals will impact silver as well as silver compounds.
The EPMF is not supporting this classification proposal because it is based on weak weight of evidence rather than robust scientific data. The EPMF has identified data gaps in the scientific database for silver, and has been proactive in filling this data gap. Under REACH, the EPMF submitted a Testing Proposal to perform an Extended One Generation Reproductive Toxicity study in 2015 for silver, which has been approved in June 2019. The testing program has just started.
EPMF believes that great care is needed in making any proposals for the Classification and Labelling of silver and silver compounds.
The EPMF profoundly regrets that the Swedish Chemical Agency has chosen to submit a classification proposal for silver nitrate in December 2018 and for silver in July 2019, and that they will soon submit another separate proposal for silver chloride without properly recognizing the scientific data gaps and without taking into account the Testing Proposal under REACH. It is frustrating for the precious metals industry to see two parallel but separate processes which have an impact on each other working in isolation and, potentially, leading to different outcomes.
The EPMF will make all necessary efforts to reconcile the two proposals and to ensure the classification is based on sound scientific evidence. To do so, the precious metals industry will need the support from its downstream users and final users, like you. If you are interested in being kept informed on the process but also in joining forces to address this new regulatory challenge, please feel free to contact the SEA so we can keep you informed/put you in direct contact with on the Silver Advocacy Task Force which should meet in the coming weeks.