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| Heavy metals control - Reg. (EU) 2023/915 | |||
|---|---|---|---|
| Batch no.: SRHCZ250301Y | |||
| Sample: The analysis is carried out on whole capsules (shell and contents), representative of the sampled batch. | |||
| Parameter | Specification | Result | Method |
| Arsenic | ALARA or ≤ 1.0 mg/kg (ppm) |
0.0276 ± 0.0069 mg/kg COMPLIES |
ICP-MS QMP_55_25_x Rev.10 Accredited method |
| Cadmium | ≤ 1.0 mg/kg (ppm) | <0.02 mg/kg COMPLIES |
|
| Lead | ≤ 3.0 mg/kg (ppm) | 0.0268 ± 0.0067 mg/kg COMPLIES |
|
| Mercury | ≤ 0.1 mg/kg (ppm) | <0.01 mg/kg COMPLIES |
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.: SRHCZ250301Y | |||
|
Sample: The analysis is carried out on whole capsules (shell and contents), representative of the sampled batch |
|||
| Parameter/Analyte | Specification | Result | Method |
| Aerobic microorganism count at 30ºC | ≤ 105 cfu/g | < 10 cfu/g COMPLIES |
PN-EN ISO 4833-1:2013- 12+A1:2022-06 (EU) Accredited method |
| Plate count of Enterobacteriaceae | < 10 cfu/g | < 10 cfu/g COMPLIES |
PN-EN ISO 21528-2:2017-08; Plate method (pour plate) (EU) Accredited method |
| Count of Escherichia coli | < 10 cfu/g | < 10 cfu/g COMPLIES |
PN ISO 16649-2:2004; Plate method (pour plate) (EU) Accredited method |
| Count of coagulase-positive staphylococci (Staphylococcus aureus and other species) |
< 10 cfu/g | < 10 cfu/g COMPLIES |
PN-EN ISO 6888-2:2022-03; Plate method (pour plate) (EU) Accredited method |
| Plate count of moulds and yeasts at 25 °C |
≤ 102 cfu/g | < 10 cfu/g COMPLIES |
PN ISO 21527-2:2009; Plate method (pour plate) (EU) Accredited method |
| Detection of Salmonella spp. | Negative/25 g | Not detected/25 g COMPLIES |
PN-EN ISO 6579-1:2017-04 + A1:2020-09; Culture method with biochemical testing and serological confirmation (EU) Accredited method |
| Detection of Listeria monocytogenes | Negative/25 g | Not detected/25 g COMPLIES |
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. Since there are no EU-harmonised microbiological criteria specifically for food supplements, the criteria indicated are based on industry best practices and risk assessment. | |||
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| Mycotoxins control (aflatoxins) - Reg. (EU) 2023/915 | |||
|---|---|---|---|
| Batch no.: SRHCZ250301Y | |||
|
Sample: Whole capsules (shell and contents) are analysed |
|||
| Parameter/Analyte | Specification | Result | Method |
| Total aflatoxins (B1+B2+G1+G2) | ≤ 4.0 µg/kg (ppb) |
< 2.0 µg/kg (ppb) |
QMP_52_04_x(TA) |
| 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 “food supplements based on botanicals”. Therefore, a conservative internal specification is used, consistent with the MLs established in that Regulation for similar categories. | |||
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| Pesticide control - Reg. (EC) 396/2005 | |||
|---|---|---|---|
| Batch no.: SRHCZ250301Y | |||
|
Sample: Whole capsules (shell and contents) are analysed |
|||
| Parameter/Analyte | Specification | Result | Method |
| Pesticide residues (multi-residue screening, 675 compounds) |
Not detected Above the method LOD/LOQ for the compounds included (675 compounds) |
No pesticides were detected by LC-MS/MS and GC-MS/MS above the method LOD/LOQ COMPLIES |
QMP_52_22_x Rev.08 Accredited method |
| NOTE: Pesticide residues (multi-residue, 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 using 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 stage 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 carry out heavy metals controls for each manufactured batch. These controls are required from its suppliers. | ||
| Maximum heavy metals content: In accordance with Regulation (EU) 2023/915. | ||
| Maximum content of polycyclic aromatic hydrocarbons (PAHs): In accordance 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 principles and general requirements of food law and food safety, in accordance with Reg. (EU) 178/2002. |
