From your Make-up to your sports clothing, it all might contain ZPT, But is Zinc Pyrithione safe? No Says Europe.
"The European Union has transmitted to the WTO (World Trade Organisation) a draft "Omnibus" Regulation aimed at amending several annexes of the Cosmetics Regulation and, in particular, at banning or regulating substances classified as CMR (carcinogenic, mutagenic or reprotoxic) within Regulation 2020/1182. These new measures will amend Annexes II, III and V and should be applicable from 1st March 2022."
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ABOUT Zinc Pyrithione
From Deodorant and dandruff shampoo to anti-fungal.
ZTP (Zinc-Pyrithione) is used in many applications which you might be using right now. Anti-Dandruff shampoos, sponges and garments are some of the many applications of this active ingredient.
Zinc Pyrithione is approved for over-the-counter topical use in the United States and many other countries as a treatment for dandruff.
Mechanism of action:
Its anti-fungal effect is thought to derive from its ability to disrupt membrane transport by blocking the proton pump that energizes the transport mechanism.
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.
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 Zinc Pyrithione from being used in all EU materials, whether cosmetic or industrial, due to its reproductive toxicity.
Zinc Pyrithione is now 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 a high acute M-factor of 1000 to the environmental classification.
The Scientific Committee on Consumer Safety (SCCS) had also found it safe up to a maximum level of 1% and 0.5% in other products. despite this recommendation a proposal from the Swedish authorities, the 15th Adaptation to Technical and Scientific Progress of the CLP Regulation (Classification, Labelling and Packaging of Substances) formalized the carcinogenic classification of category 1B; Thus banning the substance in cosmetic products, with entry into force set for 1st March 2022.
The European Commission has therefore notified the draft Regulation providing for a total ban on zinc pyrithione to the WTO, including as an anti-dandruff agent. As a matter of fact, there is no evidence that there are no suitable alternative substances available.
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.
Twenty-three substances classified as CMR (including zinc pyrithione) will be added to the list of prohibited substances in Annex II, such as Butylphenyl methylpropional, an allergen, or Sodium hydroxymethylglycinate, a preservative. Some manufacturers will therefore have to change the formulation of their products in order to remain compliant in Europe.