As of March 1st, 2022, the European Commission have officially implemented the Commission Delegated Regulation 2020/1182, which includes a revised list of prohibited ingredients for Annex I and Annex VI. An unexpected addition to the list of prohibited substances is Zinc Pyrithione, an active ingredient that has been commonly used for decades.
What is Zinc Pyrithione?
Zinc Pyrithione (ZPT) is a broad-spectrum antimicrobial that has proven efficacy against fungi, Gram-positive, and Gram-negative bacteria.
For nonmedical purposes, as it was previously offered by BioCote®, ZPT is particularly effective in dry-film anti-fungal applications. It is frequently used in exterior paints to protect against mildew and mould.
Why is it being reclassified in the EU?
Commission Delegated Regulation 2020/1182 added twenty-three chemicals to the list of prohibited substances in Annex VI, formally classifying them as carcinogenic, mutagenic, or toxic to reproduction. After entering into force on the 1st of March 2022, Regulation 2020/1182 has banned ZPT from being used in all EU materials, whether cosmetic or industrial, due to its reproductive toxicity.
Formally, ZPT now has the reclassification as a “Reprotoxic Category 1b” under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation of the EU. It has also been allocated an acute M-factor of 1000 to the environmental classification.
While the Scientific Committee on Consumer Safety (SCCS) issued a conclusion that ZPT is safe for consumers when integrated within a product at a dosage rate less than 1%, they could not confirm that ZPT is an irreplaceable chemical agent.
Global impact of the Zinc Pyrithione reclassification
Currently, ZPT has only been banned within the EU under the BPR and is still widely used throughout the world. However, provided the recent evidence to suggest that ZPT is toxic to reproduction, BioCote® have decided to permanently cease any supply of our ZPT based additive for use in treated articles.
The discontinuing of our ZPT stock will not only apply to those within the EU, but to our entire global customer base. As experts in our field, BioCote® are trusted for our intrinsic understanding of antimicrobial technology, and therefore feel that it would be irresponsible of us to sell any additives that we cannot unanimously say are safe for use in treated articles.
What is a suitable alternative?
Since BioCote® are taking a proactive stance to not supply a substance that REACH have sanctioned as harmful, we have been working hard to offer our customers a viable alternative to using ZPT within their treated products.
BioCote® are happy to announce that all customers who were previously using ZPT have now successfully transitioned over to our suggested alternative, after having appropriately trialled and validated their materials for chemical and material compatibility, as well as antimicrobial efficacy.
The newly formulated additive is intended to preserve treated articles and will act as an ideal replacement for any businesses looking to move away from using ZPT.
Learn more about our Zinc Pyrithione replacement today
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