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POTENTIAL CHANGES TO SWEDEN

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

AquaticAcute 1, M-factor=10 (powder <1mm) and M-factor=1000 (powder <0.0001mm)

AquaticChronic 1, M-factor=10 (powder <1mm)  and M-factor=100 (powder<0.0001mm)

This classification has been proposed in the context of theBiocidal Products Regulation but will apply to other regulations (e.g.: REACH)and other applications (e.g.: jewellery, electronics, solar energy etc.) aswell. Skin sensitization cat 1 could trigger a restriction for skin contactmaterials like jewels. A classification as reprotoxicant category 1B cantrigger a fast track restriction process banning all the consumer uses ofsilver and silver compounds (e.g.: no jewellery, no silverware anymore). Thisclassification will also qualified these substances for the authorisationprocess under REACH which could require an authorisation for each industrialand professional use. The final aim of these regulatory measures is thesubstitution of the classified substances by safer alternatives.

A similar proposal has already been published for silvernitrate in December 2018 and is expected for silver chloride soon. Based on theread-across strategy supported by the REACH registration dossiers, thesedifferent proposals will impact silver as well as silver compounds.

The EPMF is not supporting this classification proposalbecause it is based on weak weight of evidence rather than robust scientificdata. The EPMF has identified data gaps in the scientific database for silver,and has been proactive in filling this data gap. Under REACH, the EPMFsubmitted a Testing Proposal to perform an Extended One Generation ReproductiveToxicity study in 2015 for silver, which has been approved in June 2019. Thetesting program has just started.

EPMF believes that great care is needed in making anyproposals for the Classification and Labelling of silver and silver compounds.

The EPMF profoundly regrets that the Swedish Chemical Agencyhas chosen to submit a classification proposal for silver nitrate in December2018 and for silver in July 2019, and that they will soon submit anotherseparate proposal for silver chloride without properly recognizing the scientificdata gaps and without taking into account the Testing Proposal under REACH. Itis frustrating for the precious metals industry to see two parallel butseparate 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 thetwo proposals and to ensure the classification is based on sound scientificevidence. To do so, the precious metals industry will need the support from itsdownstream users and final users, like you. If you are interested in being keptinformed on the process but also in joining forces to address this newregulatory challenge, please feel free to contact me. We will be happy toinclude you in our Silver Advocacy Task Force  which should meet in thecoming weeks.

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