CEN/TR 17612:2021

Algae and algae products - Specifications for pharmaceutical sector applications

This document gives an overview of recommendations on product specifications, and other relevant information, for algae and algae products for pharmaceutical applications.
This document does not apply to food and feed applications.
This document does not provide instructions on handling of technical requirements in existing legislations.

Algen und Algenprodukte - Spezifikationen für Anwendungen im Pharmasektor

Algues et produits d’algues - Spécifications pour les applications dans le secteur pharmaceutique

Le présent document fournit une vue d’ensemble des recommandations relatives aux spécifications des produits ainsi que d’autres informations pertinentes pour les algues et produits d’algues dans les applications pharmaceutiques.
Le présent document ne s’applique pas aux applications de denrées alimentaires et d’aliments pour animaux.
Le présent document ne fournit pas d’instructions relatives aux exigences techniques requises selon les législations existantes.

Alge in izdelki iz alg - Specifikacije za uporabo v farmacevtski industriji

General Information

• Status: Published
• Publication Date: 26-Jan-2021
• ICS: 13.020.55 - Biobased products
• Technical Committee: CEN/TC 454 - Algae and algae products
• Drafting Committee: CEN/TC 454/WG 5 - Specifications for non-food/feed sector applications
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 27-Jan-2021
• Due Date: 08-Dec-2021
• Completion Date: 27-Jan-2021
• Directive: 2009/128/EC - Directive 2009/128/EC of the European Parliament and of the Council of 21 october 2009 establsihing a framework for Community action to achieve the sustainable use of pesticides
• Mandate: M/547 - [C(2016)1582] Standardisation request to CEN on Algae and their products
• Ref Project: SIST-TP CEN/TR 17612:2021 - Algae and algae products - Specifications for pharmaceutical sector applications

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 17612:2021
01-marec-2021
Alge in izdelki iz alg - Specifikacije za uporabo v farmacevtski industriji
Algae and algae products - Specifications for pharmaceutical sector applications
Spezifikationen für Anwendungen im Nicht-Lebensmittel-/Futtermittelsektor
Algues et produits d’algues - Spécifications pour les applications dans le secteur
pharmaceutique
Ta slovenski standard je istoveten z: CEN/TR 17612:2021
ICS:
11.120.01 Farmacija na splošno Pharmaceutics in general
SIST-TP CEN/TR 17612:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 17612:2021


CEN/TR 17612
TECHNICAL REPORT

RAPPORT TECHNIQUE

January 2021
TECHNISCHER BERICHT
ICS 13.020.55
English Version

Algae and algae products - Specifications for
pharmaceutical sector applications
Algues et produits d'algues - Spécifications pour les Spezifikationen für Anwendungen im Nicht-
applications dans le secteur pharmaceutique Lebensmittel-/Futtermittelsektor


This Technical Report was approved by CEN on 4 January 2021. It has been drawn up by the Technical Committee CEN/TC 454.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 17612:2021 E
worldwide for CEN national Members.

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CEN/TR 17612:2021 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Product characteristics . 8
4.1 Product purity . 8
4.1.1 General . 8
4.1.2 Purity of microalgae and cyanobacteria . 9
4.1.3 Purity of macroalgae . 9
4.1.4 Purity of algae derivatives or extracts . 10
4.1.5 Methods of analysis . 11
4.2 Contamination . 12
4.2.1 General . 12
4.2.2 Physical, biological and chemical contaminants . 12
4.2.3 Microbiological quality of algae and algae biomass . 12
4.2.4 Contaminants in algae and algal pharmaceutical ingredients . 13
4.3 Other product characteristics .
...