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| Heavy metals control - Reg. (EU) 2023/915 | |||
|---|---|---|---|
| Batch no.: 20240321 | |||
| Sampling: In accordance with the internal sampling procedure, a random selection is made of the number of jars defined for each batch of finished product. The sampled jars are taken sealed, with the induction seal intact and with no evidence of tampering, recording batch number, expiry date and sampled quantity. Sample: The analysis is carried out on intact capsules (shell and contents), representative of the sampled batch. |
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| 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 value obtained 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 are applied based on HACCP best practices and the ALARA principle (As Low As Reasonably Achievable) of ≤ 1 mg/kg (ppm) total arsenic. | |||
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| Microbiological control - Reg. (EU) 2023/915 | |||
|---|---|---|---|
| Batch no.: 20240321 | |||
|
Sampling: In accordance with the internal sampling procedure, a random selection is made of the number of jars defined for each batch of finished product. The sampled jars are taken sealed, with the induction seal intact and with no evidence of tampering, recording batch number, expiry date and sampled quantity. |
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| Parameter/Analyte | Specification | Result | Method |
| Aerobic plate count at 30°C | ≤ 105 cfu/g | < 10 cfu/g COMPLIES |
ISO 4833-1:2013 Accredited method |
| Enterobacteriaceae at 30°C | < 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 |
| Yeasts and moulds 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/25g | Not detected COMPLIES |
QMP_51_57_x (COMPASS) 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 (general principles and requirements of food law) and Regulation (EC) No 852/2004 (food hygiene and the obligation to apply self-monitoring systems based on HACCP). Regulation (EC) No 2073/2005, which lays down microbiological criteria for certain categories of foodstuffs, applies where relevant depending on the nature of the product. Since there are no EU-harmonised microbiological criteria specifically for food supplements, the criteria indicated in this table correspond to industry best practices (internal control specifications) for non-sterile orally administered products, based on risk assessment and intended use. The legal definition of a food supplement and its specific framework are established in Directive 2002/46/EC. | |||
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| Fish oil standardization control (Omega-3) | |||
|---|---|---|---|
| Batch no.: 20240321 | |||
|
Sampling: In accordance with the internal sampling procedure, a random selection is made of the number of jars defined for each batch of finished product. The sampled jars are taken sealed, with the induction seal intact and with no evidence of tampering, recording batch number, expiry date and sampled quantity. |
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| Parameter/Analyte | Specification | Result | Method |
| Eicosapentaenoic acid (EPA) | > 40% ± 10 % | 43.6 % ± 6.5% COMPLIES |
QMP_52_22_x Rev.08 Accredited method |
| Docosahexaenoic acid (DHA) | > 30% ± 10 % | 34.1 % ± 5.1% COMPLIES |
|
| Total Omega-3 fatty acids | > 80% ± 20 % | 89 % ± 18% COMPLIES |
|
| The product complies with the quality criteria in terms of omega-3 fatty acid standardization defined by the product specifications. | |||
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| Raw Material Specifications | ||
|---|---|---|
| Fish Oil | ||
|
Batch no.: 20240321 (Raw material Batch no.: 400300-240311) |
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| Parameter/Analyte | Specification | Result |
| PCBs (non-dioxin-like – indicator IC6: 28, 52, 101, 138, 153, 180) | ≤ 0.175 mg/kg (ppm) ❶ [175 µg/kg (ppb)] |
< 0.01 mg/kg* |
| Dioxin-like PCBs (PCBs with dioxin-like activity – expressed as TEQ) | ≤ 4.0 pg/g (ppt) ❶ | < 3 pg/g (complies)* COMPLIES |
| PCDDs + PCDFs (Dioxins + Furans) | ≤ 1.75 pg/g (ppt) ❶ | < 1 pg/g (complies)* COMPLIES |
| PCDDs + PCDFs + dioxin-like PCBs (total TEQ) |
≤ 6.0 pg/g (ppt) ❶ | < 3 pg/g (complies)* COMPLIES |
| Acid value | ≤ 1.0 mg KOH/g ❷ | 0.1 mg KOH/g COMPLIES |
| Peroxide value | ≤ 5.0 meq/kg ❷ | 1.0 meq/kg COMPLIES |
| Anisidine value |
≤ 20.0 ❷ | 4.1 COMPLIES |
| Total oxidation (TOTOX) | ≤ 26.0 ❷ |
6.1 |
| ❶ According to Regulation (EU) 2023/915. | ||
| ❷ The criteria indicated correspond to industry best practices (internal control specifications) for fish oils. | ||
| *: The symbol "<" preceding a result means that the value obtained is below the limit of quantification. | ||
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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-irradiated: No ionising radiation is used at any stage during the product manufacturing process in accordance with Directives 1999/2/EC and 1999/3/EC. |
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| 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 metal controls for each manufactured batch. These controls are required from its suppliers. | ||
| Maximum heavy metal 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: In accordance with Regulations (EU) 2015/2075 and (EC) 396/2005. | ||
| BSE / TSE: The product is free from any BSE / TSE risk according to Regulation (EC) 999/2001. | ||
| Product manufactured in compliance with the general principles and requirements of food law and food safety, in accordance with Reg. (EU) 178/2002. |
