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| Heavy metals control - Reg. (EU) 2023/915 | |||
|---|---|---|---|
| Batch no.: 20240326 | |||
| Sample: The analysis is carried out on intact 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 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) | <0.02 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 obtained value is below the limit of quantification. | |||
| NOTE: Regulation (EU) 2023/915 does not establish a specific maximum limit for arsenic in food supplements. Therefore, internal specifications based on the ALARA principle ≤ 1 mg/kg (ppm) of total arsenic are applied. | |||
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| Microbiological control - Reg. (EU) 2023/915 | |||
|---|---|---|---|
| Batch no.: 20240326 | |||
|
Sample: The analysis is carried out on intact capsules (shell and content), representative of the sampled batch |
|||
| Parameter/Analyte | Specification | Result | Method |
| Aerobic microorganisms plate count at 30ºC | ≤ 105 cfu/g | < 10 cfu/g COMPLIES |
ISO 4833-1:2013 Accredited method |
| Enterobacteriaceae at 30ºC | < 10 cfu/g | < 10 cfu/g COMPLIES |
ISO 21528-2:2017 Accredited method |
| Escherichia coli ß-glucuronidase positive at 44 °C | < 10 cfu/g | < 10 cfu/g COMPLIES |
ISO 16649-2:2001 Accredited method |
| Coagulase-positive Staphylococci | < 10 cfu/g | < 10 cfu/g COMPLIES |
ISO 6888-2:2021 Accredited method |
| Moulds and yeasts at 25 °C | ≤ 102 cfu/g | < 10 cfu/g COMPLIES |
NF V 08-059: 2002 Accredited method |
| Salmonella spp. | Negative/25g | Not detected COMPLIES |
ISO 6579-1:2017 Accredited method |
| Listeria monocytogenes | Negative/cfu/g | Not detected COMPLIES |
QMP_51_57_x (COMPASS) Accredited method |
| NOTE: The symbol “<” preceding a result means that the obtained value is below the limit of quantification. | |||
| NOTE: In the European Union, the safety of food supplements is governed by Regulations (EC) No. 178/2002 and No. 852/2004. As there are no harmonised EU microbiological criteria specifically for food supplements, the criteria indicated in this table correspond to industry best practices based on risk assessment. | |||
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| Standardisation control of gamma-linolenic acid (GLA) and total Omega-6 fatty acids | |||
|---|---|---|---|
| Batch no.: 20240326 | |||
|
Sample: The analysis is carried out on the internal content of the capsule. |
|||
| Parameter/Analyte | Specification | Result | Method |
| Gamma-linolenic acid (GLA) |
12.0 % ± 10 % (10.8 % - 13.2 %) |
11.8 % ± 1.8 % (11.6 % - 12.0%) |
QMP_52_22_x Rev.08 Accredited method |
| Total Omega-6 fatty acids | > 70% ± 20 % |
71 % ± 14 % |
|
| The product complies with the quality criteria in terms of GLA standardisation and total omega-6 fatty acids defined by the product specifications. | |||
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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 the labelling requirements in accordance with Regulation (EC) 1829/2003. | ||
| Non-irradiated: Ionising radiation is not 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 its subsequent amendments. The supplier Pharmatech Asia Group Ltd does not carry out heavy metal controls for each manufactured batch. These controls are required from its suppliers. | ||
| Maximum heavy metals content: In accordance with Regulation (EU) 2023/915. | ||
| Maximum polycyclic aromatic hydrocarbons (PAHs) content: 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: Pesticides: In accordance with Regulations (EU) 2015/2075 and (EC) 396/2005. | ||
| BSE / TSE: The product is free from any risk of BSE / TSE in accordance with Regulation (EC) 999/2001. | ||
| Product manufactured in compliance with the principles and general requirements of food law and safety, in accordance with Reg. (EU) 178/2002. |
