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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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 . 16
4.3.1 Identification . 16
4.3.2 Particle size . 16
4.3.3 Foreign matter . 16
4.3.4 Total ash, insoluble ash . 17
4.3.5 Extractable matter . 17
4.3.6 Swelling index . 17
4.3.7 Bitterness value . 17
4.3.8 Loss on drying . 17
4.3.9 Water (for herbal drugs with high essential oil content) . 17
4.3.10 Assay . 18
5 Storage . 18
6 Labelling . 18
7 Product information documents . 19
7.1 General . 19
7.2 Material Safety Data Sheet . 19
7.3 Other relevant product information . 19
7.3.1 Origin . 19
7.3.2 Strain origin . 19
7.3.3 Product origin . 19
7.4 Protected species . 19
7.5 Algae extracts . 20
8 Sustainable development . 20
8.1 General . 20
8.2 United Nations sustainable development goals . 20
8.3 Sustainable development of macroalgae production . 20
8.4 Sustainable development of microalgae production . 21
9 Traceability . 21
9.1 General . 21
9.2 Chain of Custody . 22
10 Algae in EP and USP General monographs. 22
Annex A (informative) Regulatory framework . 23
Annex B (informative) Raw Material Specifications examples . 24
Annex C (informative) Technical Data Sheets (TDS) examples. 27
Annex D (informative) Origin of algae products . 30
Annex E (informative) Algae extracts . 33
Annex F (informative) Purity identification methods and gap analysis algae . 36
Bibliography . 38

European foreword
This document (CEN/TR 17612:2021) has been prepared by Technical Committee CEN/TC 454 “Algae
and algae products”, the secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
The European committee for Standardization (CEN) was requested by the European Commission (EC) to
draft European standards or European standardization deliverables to support the implementation of
Article 3 or Directive 2009/28/EC for algae and algae products or intermediates. The request presented
as Mandate M/547, also contributes to the Communication on “Innovating for Sustainable Growth: A Bio
economy for Europe”.
The former working group CEN Technical Board Working Group 218 “Algae” was created in 2016 to
develop a work programme as part of the Mandate. The technical committee CEN/TC 454 “Algae and
algae products” was established to carry out the work program the secretariat of which is held by NEN.
CEN/TC 454 set up a number of topic specific working Groups listed below to develop standards for algae
and algae products.
This document has been prepared by Working Group 5 “Specifications for the pharmaceutical
applications sector” with the support of UNI as the secretariat, in close collaboration with the other
CEN/TC 454 working groups:
CEN/TC 454/WG 1 “Terminology”;
CEN/TC 454/WG 2 “Identification”;
CEN/TC 454/WG 3 “Productivity”;
CEN/TC 454/WG 4 “Specifications for food/feed sectors applications”;
CEN/TC 454/WG 6 “Product test methods”.
Algae-based products and intermediates, in this TR referred to as ‘products’, are defined as whole
biomass, extracts or derivatives from algae, including a.o. algae oil and algal meal.
This document will allow the stakeholders to have access to a clear point of reference on the use of algae
in pharmaceutics.
Pharmacy had standards which date back to ancient Egypt; through the first pharmacopoeias which were
the Arab one, the Totum continens (Elhavi) of ar-Razi, and that of the Salerno medical school.
Then national Pharmacopoieas developed in Europe in the Eighteenth Century.
Today pharmacetical industry has the European Pharmacopoiea (EP) [3], with legal status according
medicinal regulatory framework (Annex A), being harmonized with American (USP) [4] and Japanese (JP)
[5] through ICH [6].
Introduction
The interest in algae and algae-based products or intermediates as a renewable and sustainable source
of carbohydrates, proteins, lipids and pigments has increased significantly in Europe.
The purpose of this document prepared by WG 5 is to provide an overview on how quality indicating
parameters for algae and algae-based products and intermediates relevant for pharmaceutical
applications can be handled and to identify the need for any future standard developments for
pharmaceutical applications. Algae are highly available and used in many countries as fertiliser,
biostimulant, animal feed, medicine, cosmetic and food ingredients, and have different compounds
depending on species.
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitut
...