CONIUNCTA provides comprehensive technical documentation for every product. These documents are essential for quality assurance, regulatory compliance, and product development.

Access to Documents

TDS, SDS and CDS are available for download to registered customers after login on each product page under the "Technical Documentation" tab. The Certificate of Analysis is provided batch-specifically after purchase completion, either with the delivery or by e-mail.

Technical Data Sheet (TDS)

The TDS is the central product data sheet for formulation development and regulatory documentation. The structure varies depending on the product category:

Liquid Extracts

For liquid extracts, a separate TDS exists for each carrier. "Paracress Extract" accordingly has several data sheets (Pentylene Glycol 61507, Propylene Glycol 61508, Glycerin 61509). The same applies to oil extracts with different carrier oils; weight variants (250 g, 500 g, 1 kg) are consolidated in the respective TDS.

Powder Extracts

Powder extracts have one TDS per product and include additional specifications such as extract ratio (e. g. 10:1), particle size, loss on drying, and detailed test parameters with test methods.

Contents of the TDS

• Product Identification: SKU, product name, type, carrier medium, revision status
• Certification Status: Conformity with (EC) No. 1223/2009 and (EU) No. 1169/2011
• INCI Names: Global INCI Name and EU INCI Name
• Natural Status: NOI according to ISO 16128, RSPO, COSMOS/NaTrue, vegan, kosher, and halal status
• Composition: INCI components with concentration range, CAS and EINECS numbers
• Manufacturing Process: Extraction method (CONIUNCTA® AVE), solvent, DER values
• Regulatory Status: SVHC, food-grade, BSE/TSE, CMR, GMO, REACH, solvent residues
• Allergen Information: Fragrance allergens pursuant to Annex III (updated in accordance with (EU) 2023/1545)
• Product Properties: Organoleptics, pH, density, refractive index, microbiological status
• Application: Areas of use, dosage, active ingredient classes, shelf life, storage, packaging

For food-grade products, the TDS additionally contains an ingredient list, nutritional table, and information on irradiation, nanomaterials, GMO, gluten, and novel food status.

Safety Data Sheet (SDS)

The safety data sheet complies with REACH Regulation (EC) No. 1907/2006. Unlike the TDS, one SDS may cover several product variants, provided these are identical in terms of safety (e. g. the SDS for Paracress Extract applies to all three carrier variants 61507/61508/61509).

Structure of the SDS (16 Sections)

1. Identification of the substance/mixture and of the company
2. Hazards identification (classification according to CLP (EC) No. 1272/2008)
3. Composition / information on ingredients
4. First aid measures
5. Firefighting measures
6. Accidental release measures
7. Handling and storage (storage class according to TRGS 510)
8. Exposure controls / personal protection
9. Physical and chemical properties
10. Stability and reactivity
11. Toxicological information
12. Ecological information
13. Disposal considerations
14. Transport information (ADR/RID, IMDG, IATA)
15. Regulatory information
16. Other information

The majority of CONIUNCTA extracts are not classified as hazardous substances under CLP and are not subject to special transport regulations.

Claim Data Sheet (CDS)

The Claim Data Sheet describes the characteristic phytochemical profile of an extract and derives from it what the extract delivers in a formulation. It complements the TDS and SDS with the active side: lead marker, calculated content, sources and claim areas.

Structure of the CDS

1. Characteristic phytochemical profile: product, INCI, composition and carrier variants, manufacturing (CONIUNCTA® AVE), drug-to-extract ratio (DER), use level
2. At a glance: lead marker, marker quantity delivered at the reference use level, mechanistic background (not a product claim)
3. Quantitative marker calculation: lead marker and compound class, literature content in the dried plant with source (Ph. Eur., ESCOP, peer-reviewed literature), calculated range in the product, calculation basis (literature content × extraction ratio × yield), data basis
4. Supported claim areas (cosmetics): areas supported by the phytochemical profile and the literature; substantiation rests with the finished product manufacturer under Regulation (EU) No 655/2013
5. Industry suitability and regulatory notes: cosmetics under (EC) No 1223/2009, food including novel food status under (EU) 2015/2283, fragrance allergens, phototoxicity, vegan suitability
6. Analytical data: determination of individual marker compounds by HPLC/DAD, GC/MS or LC-MS as an additional service, batch-specific certificates of analysis for defined markers
7. Summary

How to read the marker calculation

The content in the product is a calculated range: literature content in the dried plant, multiplied by the extraction ratio and the extract fraction, corrected for the extraction yield. Example witch hazel flower extract: 3 to 10 % tannins in the dried plant (Ph. Eur., ESCOP), extraction ratio 1:10 with a 30 % extract fraction, 70 to 90 % yield, giving 0.6 to 2.7 mg/ml hamamelitannin in the extract. Actual batch values may deviate depending on raw material quality, harvest and process parameters; batch-specific confirmation by HPLC is available on request.

The CDS contains no health claims for food and does not replace a safety assessment. Like the TDS and SDS, it is available for download to registered customers after login on every product page.

Certificate of Analysis (CoA)

The certificate of analysis documents the actual test results of the delivered batch. It is provided after purchase completion, by email with the shipping notification, as an enclosure with the delivery, or upon request through our Regulatory Affairs department.

Typical CoA Parameters

• Batch identification: Lot/Batch, manufacturing date, best before date
• Organoleptic testing: Appearance, colour, odour
• Physicochemical parameters: pH value, relative density, refractive index
• Microbiological testing: TAMC, TYMC, absence of E. coli, P. aeruginosa, S. aureus, C. albicans
• Heavy metals: Lead, cadmium, mercury, arsenic (where tested)
• Release statement: Confirmation of specification compliance by QC

Batch-specific documentation is required for internal quality assurance, the preparation of safety assessments (CPSR), as well as for regulatory enquiries and audits.