TDS is available on /en/our-extracts/products/; you can access it by clicking on ‘Technical Datasheet’ button, after a quick and simple registration.

TDS is organized in two sections:

1. general information on the plant and relevant extract, which are retrieved from suppliers (i.e. agronomical data), Italian Ministry of Health (i.e. physiologic and healthcare applications) and bibliographical data (i.e. active substances of the plant).
2. analytical information and technical specifications: analytical methods are usually retrieved from Ph. Eur. current edition, except where otherwise specified. The following symbol (*) identifies analysis performed on a specific self-control plan. TDS only reports analytical data within a range of acceptability, while batch-specific results are reported on the CoA.

Additional information about TDS

1. GMO, BSE-TSE and GLUTEN free information are reported on TDS.
2. Residual solvents are not reported for extracts produced using water as the only solvent. For all other extracts, compliance with current Directive on matter of residual solvents are reported on TDS.
3. For standardized extract only the analytical marker percentage is indicated in TDS; the DER (Drug-Extract ratio) is not indicated since it depends on the concentration of the analytical markers that must be achieved in the final extract. If DER is mandatory (according to local law authorities i.e. for product registration), a statement will be issued, upon indication of the local Regulation in force.
4. When DER is specified, it represents the final ratio (including excipients) and not native ratio, as reported in TDS.
5. Physiologic and healthcare applications do not refer to EFSA or FDA approved claim; data is usually retrieved from Ministerial Decree 9 January 2019 annex I.
6. TDS has no expiry date. This document is:
   1. updated, when new information that does not alter any manufacturing characteristics (i.e. country of plant origin, collection period) becomes available; updated versions are always available at /en/our-extracts/products/.
   2. revised, when new information that possibly affects the extract characteristics (i.e. new excipient) becomes available; revised versions are always communicated to Customers by e-mail according to current Change Control SOP.
7. Organoleptic data (i.e. color) is reported in section 2 of TDS and has wide range of acceptability due to natural vegetal raw material variability, without affecting the extract quality.
8. The nutritional values reported in the first section of TDS are merely indicative; the analysis is mandatory for finished products only.

For liquid extract, over time, a slight sediment may form on standing, as reported by Ph.Eur. 10^th edition. The phenomenon is due to hydro-dispersible substances of the phytocomplex (e.g. fibers and tannins) and does not affect the final quality of the extract, indeed, it demonstrates its naturalness.

MSDS or handling, storage and transport information is available on /en/our-extracts/products/ , you can access this information by clicking on ‘Healthy and Safety data’ button, after a fast and simple registration.

MSDS is available only for those extracts classified as dangerous or containing dangerous substances according to Reg. 1272/2008 (CLP), Reg. (EC) 1907/2006 (REACH) and subsequent amendments and updates.

If the extract or none of its components is not classified as dangerous according to Reg. 1272/2008 (CLP), Reg. (EC) 1907/2006 (REACH) and a document with handling, storage and transport information is issued.

Allergen form is available on /en/our-extracts/products/ , by clicking on ‘Allergen’ button, after a fast and simple registration. This document includes the compositional breakdown with the relative percentage of all components of the extract (which is considered a mixture).

The allergen form differs according to the end-use of the product:

– Glycolic extracts are considered for cosmetic use only and the presence of allergens is retrieved from bibliographical data.

– All other extracts suitable for food and food supplement industry have a different allergen form, which is drafted based on the list of food allergens according to annex II of Reg. (EU) 1169/2011 on the provision of food information to consumers. The presence of allergens is based on bibliographical data of plant components and on our self-monitoring plan. Moreover, in order to reduce cross-contamination, EPO applies a specific procedure to validate the cleaning of manufacturing facilities and equipment used for those products containing allergens.

ISO 9001-2015, Kosher, Halal and Organic certificates can be downloaded from /en/our-strenghts/

TDS annex is a general document reporting the most requested statements according to EU food legislation: nanomaterials, irradiation, melamine, origin country of extract, source (vegetal, synthetic, animal, etc…), ethylene oxide, radioactivity, latex, packaging, HACCP system, food grade statement, REACH and CLP compliance.

Flow chart can be issued as a code-specific or type-specific document.

If an extract is 100% manufactured by EPO, the flow chart is generally issued as type specific.

If an extract is not 100% manufactured by EPO, the flow chart is a code-specific document, as it also displays information retrieved from the qualified EPO’s Supplier.

EPO performs the analysis of critical control points (CCP) for foods health and hygiene safety and since year 2001 has implemented a system (HACCP) in accordance with Reg. (EC) n. 852/2004 of the European Parliament and the Council of 29 April 2004 for hygiene of foodstuffs,. CCP are reported in the flow chart.

• Elementary Impurities: EPO extracts are food grade products, therefore this request is not applicable. Heavy metals are checked according to Reg. (EC) 1881/2006, based on self-monitoring plan
• Vegan declaration: general statement available
• WADA declaration: general statement available
• Absence of CMR: it is issued upon request

The certificate of analysis is a batch-specific document reporting all the analytical information and technical specifications. This document is automatically sent by e-mail when the goods are delivered.

The CoA reports the date of extract production based on the shelf life, which is determined on our knowledge and on a set of short- and long-term analysis of the data collected in the past (e.g. stability test).

The expiry date has been replaced by the retest date, i.e. the time from which it is possible to test the batch again to evaluate/monitor analytical data and technical specifications.