Zano® M Plus

Allergens

• Regulation (EC) n°1223/2009 as amended: Zano® M Plus is free of allergens.
• Regulation (EC) 1169/2011 – Annex II: Based on our best knowledge, the listed food allergens are not likely to be present in Zano® M Plus.

Gluten

This raw material is, based on best of our knowledge, free of gluten.

Substances Prohibited

This raw material does not contain any of the substances listed in Annex II ('List of substances prohibited in cosmetic products') of the European Commission's Cosmetic Ingredient Database (CosIng).

GMO

Zano® M Plus does not contain and/or is manufactured from Genetic Manipulated Organisms (GMO).

Microbial stability

Zano® M Plus being mostly a zinc oxide (CAS: 1314-13-2) powder, is free of micro-organisms. Zinc oxide is known to present bacteriostatic properties.

BSE/TSE

Zano® M Plus is free of animal derived ingredients. As a result, Zano® M Plus is free of Transmissible Spongiform Encephalopathy (TSE), including Bovine Spongiform Encephalopathy (BSE).

Animal testing

Zano® M Plus has not been the subject of animal testing or retesting for cosmetic purposes by or on behalf of EverCare.

Residual Solvent

Zano® M Plus process results to potential residual solvents as follows.

VOC

The only possible trace of residual solvent in Zano® M Plus is ethanol. Zano® M Plus is totally free of any other Volatile Organic Compounds (VOC).

SVHC

Zano® M Plus does not contain any Substances of Very High Concern (SVHC) as listed on the ECHA Website in the “Candidate List of Substances of Very High Concern for authorisation”, last up-dated 8th of July 2021, in a concentration above 0.1%.

CMR

Zano® M Plus is not manufactured using substances classified as CMR (Carcinogenic, Mutagenic, Toxic for reproduction). Moreover, under normal and foreseeable circumstances Zano® M Plus would not be expected to contain any substances classified as CMR above generally acknowledged regulatory standards or technical limit guidelines.

CITES

Zano® M Plus does not contain any plants which are protected by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

Halal

Zano M Plus:

• During the surface treatment, it should not be excluded that some trace of ethanol is still present in the Zano® M Plus. The trace level is specified at maximum 1% based on loss on drying (2 hours @105°c), total of moisture and Ethanol.
• Does not contain nor come into contact with animal derived materials during manufacture and storage.
• Zano® M Plus is manufactured and tested in compliance with GMP Part II / ICH Q7 requirements
• Therefore, infringement of Islamic food laws is, based on our best knowledge and quality standards, limited. An official certificate to this effect is not available.

Kosher

This raw material is not derived from, nor does it contain pork and/or pork derivatives. Therefore, infringement of Jewish food laws is, based on our best knowledge, excluded. An official certificate to this effect is not available.

Vegan

• This raw material is free of animal* origin and no animal* product, by-product or derivative are used within manufacturing process (e.g.additives, carrier substances, auxiliary materials like e.g. nutrient media used for fermented-based ingredients).
• The term animal refers to the entire animal kingdom, that is all vertebrates and all multicellular invertebrates.
• Zano® M Plus is consequently compliant with vegan standards.

Conflict Minerals

Zano® M Plus is used free of Conflict Minerals as defined by the Dodd-Frank Act (e.g. gold, tin, tantalum, and tungsten emanating from the Democratic Republic of Congo (DRC) and adjoining countries (DRC countries)).

Proposition 65

• No ingredients going in to the composition of the Zano® M Plus are listed under the California Proposition 65.
• Moreover Zano® M prior coating typically contains trace impurities of cadmium < 10 ppm, lead oxide < 20 ppm (expressed as Lead) and arsenic < 5 ppm which are known to the state of California to cause cancer or reproductive toxicity as listed under Proposition 65 State Drinking Water and Toxic Enforcement Act.

Palm Origin

This material does not contain palm oil derived ingredients.

Heavy Metals

• Monitoring of heavy metals is carried out on a regular basis.
• If present, trace heavy metal levels in Zano® M prior coating will be well within the limits of the American (USP) and European (EP) pharmacopeia.

Microplastics

This material is not and does not contain microplastics.

Impurities

The presence of any impurities is non-intended and technically unavoidable in good manufacturing practice.

Not certified

REACH

• All the substances going into the composition of the Zano® M Plus are registered and compliant with current Reach regulations EC n° 1907/2006.
• Zano® M Plus is a zinc oxide with a surface treatment with the following composition:

• As European manufacturer of the zinc oxide (EINEC number 215-222-5), the registration reference for EZUF NL B.V is 01-2119463881-32-0212..
• As a down-stream user, only supplier(s) of Triethoxycaprylylsilane with confirmed and effective REACH registration are used (based REACH registration number: 01-2119972313-39).

FDA

• EZUF NL B.V is registered as drug establishment with F.E.I number 3016994900.
• Zano® M Plus is registered with the US FDA with the NDC code 15613-310.
• Zano® M Plus is compliant for OTC products on US market.

Regulation (EC) n°1223/2009 as amended

Zano® M as zinc oxide (CAS: 1314-13-2), is

• Not listed in annex II & III of the Cosmetic regulation EU n° 1223/2009, as amended on prohibited and/or restricted substances.
• Not listed on the positive list for preservers.
• Zinc oxide listed in Annex VI to the Cosmetic Regulation EC 1223/2009 as amended can be used as UV filter up to 25%. Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
• The use of zinc oxide as a color in cosmetic product is restricted for application where deep lung exposure is possible. When used as colorants, Zano® M Plus must be called CI 77947.

Global Regulatory compliance / suncare products

Zano® M Plus is compliant for use in sunscreen products globally with following restrictions:

Keep in closed container, out of humidity and sun/light exposure.