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Product Specifications

PROTECARDIO

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Heavy metal control - Reg. (EU) 2023/915
Batch No.: 20250811
Sample: The analysis is performed on whole capsules (shell and content), representative of the sampled batch.
Parameter	Specification	Result	Method
Arsenic	ALARA or ≤ 1.0 mg/kg (ppm)	<0.02 mg/kg COMPLIANT	ICP-MS QMP_55_25_x Rev.10 Accredited method
Cadmium	≤ 1.0 mg/kg (ppm)	<0.02 mg/kg COMPLIANT
Lead	≤ 3.0 mg/kg (ppm)	<0.02 mg/kg COMPLIANT
Mercury	≤ 0.1 mg/kg (ppm)	<0.01 mg/kg COMPLIANT	ICP-MS QMP_55_26_x Rev.07 Accredited method
NOTE: The symbol “<” preceding a result means that the value obtained is below the limit of quantification.
NOTE: Regulation (EU) 2023/915 does not establish a specific maximum limit for arsenic. Therefore, internal specifications based on the ALARA principle ≤ 1 mg/kg of total arsenic are applied.

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Microbiological control - Reg. (EU) 2023/915
Batch No.: 20250811
Sample: Analysis is performed on whole capsules (shell and content), representative of the sampled batch
Parameter/Analyte	Specification	Result	Method
Aerobic microbial count 30ºC	≤ 10⁵cfu/g	< 10 cfu/g COMPLIANT	PN-EN ISO 4833-1:2013- 12+A1:2022-06 (EU) Accredited method
Plate count of Enterobacteriaceae	< 10 cfu/g	< 10 cfu/g COMPLIANT	PN-EN ISO 21528-2:2017-08, Plate method (pour-plate technique) (EU) Accredited method
Escherichia coli count	< 10 cfu/g	< 10 cfu/g COMPLIANT	PN ISO 16649-2:2004, Plate method (pour-plate technique) (EU) Accredited method
Coagulase-positive Staphylococci count (Staphylococcus aureus and other species)	< 10 cfu/g	< 10 cfu/g COMPLIANT	PN-EN ISO 6888-2:2022-03, Plate method (pour-plate technique) (EU) Accredited method
Plate count of yeasts and moulds at 25 °C	≤ 10²cfu/g	< 10 cfu/g COMPLIANT	PN ISO 21527-2:2009, Plate method (pour-plate technique) (EU) Accredited method
Detection of Salmonella spp.	Negative/25 g	Not detected/25 g COMPLIANT	PN-EN ISO 6579-1:2017-04 + A1:2020-09, Culture method with biochemical test and serological confirmation (EU) Accredited method
Detection of Listeria monocytogenes	Negative/25 g	Not detected/25 g COMPLIANT	PN-EN ISO 11290-1:2017-07, Culture method with biochemical confirmation (EU) Accredited method
NOTE: The symbol “<” preceding a result means that the value obtained is below the limit of quantification.
NOTE: In the European Union, the safety of food supplements is governed by Regulation (EC) No 178/2002 and Regulation (EC) No 852/2004. As there are no harmonised microbiological criteria at EU level specifically for food supplements, the criteria shown are based on industry best practices and risk assessment.

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Mycotoxin control (aflatoxins) - Reg. (EU) 2023/915
Batch no.: 20250811
Sample: Whole capsules (shell and content) are analysed
Parameter/Analyte	Specification	Result	Method
Aflatoxins B1	≤ 2.0 µg/kg (ppb)	< 0.50 µg/kg (ppb) COMPLIES	QMP_52_22_x Rev.08 Accredited method
Total aflatoxins (B1+B2+G1+G2)	≤ 4.0 µg/kg (ppb)	< 2.0 µg/kg (ppb) COMPLIES	QMP_52_22_x Rev.08 Accredited method
NOTE: The symbol “<” preceding a result means that the value obtained is below the limit of quantification.
NOTE: As of the date of application of Regulation (EU) 2023/915, there is no specific maximum level (ML) for aflatoxins applicable to “botanical-based food supplements”. Therefore, a conservative internal specification is used, consistent with the MLs established in the aforementioned Regulation for similar categories.

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Mycotoxin control (citrinine) - Reg. (EU) 2023/915
Batch no.: 20250811
Sample: Whole capsules (shell and content) are analysed
Parameter/Analyte	Specification	Result	Method
Citrinine	≤ 100 µg/kg (ppb)	< 10 µg/kg (ppb) COMPLIES	Internal method GC-LC/MS/MS Institut Kurz 2 GmbH*
* Test performed by INSTITUT KURZ 2 GmbH, Nattermannallee 1, 50829 Köln (ISO/IEC 17025:2018 certified laboratory)
NOTE: The symbol “<” preceding a result means that the value obtained is below the limit of quantification.
NOTE: In the EU, for food supplements based on red yeast rice (Monascus purpureus), a legal maximum limit for citrinine of 100 µg/kg (ppb) applies, in accordance with Regulation (EU) 2023/915 (maximum levels of certain contaminants in food). The determination is carried out on whole capsules (shell and content) as a representative sample of the product as consumed by the consumer.

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Pesticide control - Reg. (EC) 396/2005
Batch No.: 20250811
Sample: Analysis is performed on whole capsules (shell and content)
Parameter/Analyte	Specification	Result	Method
Pesticide residues (multiresidue screening, 675 compounds)	Not detected Above the LOD/LOQ of the method for the compounds included (675 compounds)	No pesticides have been detected by LC-MS/MS and GC-MS/MS above the LOD/LOQ of the method COMPLIANT	QMP_52_22_x Rev.08 Accredited method
NOTE: Pesticide residues (multiresidue, 675 compounds), QuEChERS extraction according to EN 15662:2018 (mod., according to laboratory validation) and instrumental determination by LC-MS/MS and GC-MS/MS.

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Additional information
Non-GMO: The product is not manufactured with genetically modified organisms or ingredients produced from genetically modified organisms, as defined in Regulation (EC) 1829/2003 and Regulation (EC) 1830/2003. Therefore, the product is not subject to labelling requirements in accordance with Regulation (EC) 1829/2003.
Non-ionised: No ionising radiation is used at any point during the product manufacturing process, in accordance with Directives 1999/2/EC and 1999/3/EC.
Contaminants: In accordance with Commission Regulation (EC) No 629/2008 of 2 July 2008 amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs and subsequent amendments. The supplier Pharmatech Asia Group Ltd does not perform heavy metal controls per manufactured batch, these controls are required from its suppliers.
Maximum heavy metal content: In compliance with Regulation (EU) 2023/915.
Maximum content of polycyclic aromatic hydrocarbons (PAHs): In compliance with Regulation (EU) 2023/915.
Nanomaterials: No ingredients in the form of nanomaterials are used, in accordance with Regulation (EU) 1169/2011.
Pesticides: In accordance with Regulations (EU) 2015/2075 and (EC) 396/2005.
BSE / TSE: The product is free from any risk of BSE / TSE according to Regulation (EC) 999/2001.
Product manufactured in compliance with the general principles and requirements of food legislation and safety, in accordance with Reg. (EU) 178/2002.