CEN/TR 17611:2021

SLOVENSKI STANDARD
01-marec-2021
Alge in izdelki iz alg - Specifikacije za uporabo v kozmetiki
Algae and algae products - Specifications for cosmetic sector applications
Algen und Algenprodukte - Spezifikationen für Anwendungen im Kosmetikbereich
Algues et produits d’algues - Spécifications pour les applications dans le secteur de la
cosmétique
Ta slovenski standard je istoveten z: CEN/TR 17611:2021
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN/TR 17611
TECHNICAL REPORT
RAPPORT TECHNIQUE
January 2021
TECHNISCHER BERICHT
ICS 13.020.55; 71.100.70
English Version
Algae and algae products - Specifications for cosmetic
sector applications
Algues et produits d'algues - Spécifications pour les Algen und Algenprodukte - Spezifikationen für
applications dans le secteur de la cosmétique Anwendungen im Kosmetikbereich

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 17611:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Product characteristics . 6
4.1 Product purity . 6
4.1.1 General . 6
4.1.2 Purity of microalgae . 7
4.1.3 Purity of macroalgae . 8
4.1.4 Purity of algae derivatives or extracts . 8
4.1.5 Methods of analysis . 9
4.2 Contamination . 10
4.2.1 General . 10
4.2.2 Physical, biological and chemical contaminants . 10
4.2.3 Contaminants in algal cosmetic ingredients . 10
5 Product information documents . 12
5.1 General . 12
5.2 Material Safety Data Sheet . 13
5.3 Other relevant product information . 13
5.3.1 Origin . 13
5.3.2 Algae extracts . 13
5.3.3 Safety . 13
5.3.4 Safety Assessment - CPSR (Cosmetic Product Safety Report) . 15
6 Sustainable development . 15
6.1 General . 15
6.2 United Nations sustainable development goals . 15
6.3 Sustainable development of macroalgae production . 15
6.4 Sustainable development of microalgae production . 16
7 Traceability . 16
7.1 General . 16
7.2 Chain of Custody . 17
8 Labelling . 17
Annex A (informative) Regulatory framework. 19
Annex B (informative) RMS and TDS examples . 23
Annex C (informative) Origin of algae products . 32
Annex D (informative) Algae extracts . 35
Annex E (informative) Purity identification methods and gap analysis algae . 38
Bibliography . 40
European foreword
This document (CEN/TR 17611:2021) 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 of 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 non-food/feed sector
applications” 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”.
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 cosmetic applications can
be handled and to identify the need for any future standard developments for cosmetic applications.
Macroalgae 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 cosmetics industry.
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
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 16751, Bio-based products - Sustainability criteria
EN 16760, Bio-based products - Life Cycle Assessment
EN 16848, Bio-based products - Requirements for Business to Business communication of characteristics
using a Data Sheet
EN 16935, Bio-based products - Requirements for Business-to-Consumer communication and claims
EN 17399, Algae and algae products - Terms and definitions
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 17399 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
algae and algae products
functional group of organisms consisting of microalgae, macroalgae, cyanobacteria, labyrinthulomycetes
and products derived thereof
3.2
Raw Material Specification
RMS
several pages technical dossier about the product, usually prepared by manufacturer, directed to provide
all product approval information to the customer and usually attached to commercial contract
Note 1 to entry: Models of RMS for some algae categories are attached as Annex B.
3.3
Technical Data Sheet
TDS
one (few) page technical document showing the technical (biochemical) parameters adopted to
characterize the product and therefore being the paradigm of the Certificate of Analysis (CoA)
Note 1 to entry: It includes ranges of different parameters used to define the product characteristics or applicable
regulatory limits.
Note 2 to entry: Models of TDS for some algae categories are attached as Annex B.
3.4
Certificate of Analysis
CoA
one (few) page document issued from laborator(ies) and reporting test results for a specific lot, usually
in front of TDS parameters, including references to test method
Note 1 to entry: It may have legal status.
3.5
Material Safety Data Sheet
MSDS or SDS
document issued with the aim of providing information about product compliance in respect of human
health and safety at the workplace and protection of the environment
3.6
sustainable development
development that meets the environmental, social and economic needs of the present without
compromising the ability of future generations to meet their own needs
[SOURCE: ISO Guide 82:2019, 3.2]
4 Product characteristics
4.1 Product purity
4.1.1 General
The product purity is defined by the percentage of specific component in the total amount of product or,
in case of whole algal biomass, by species/strain amount as percentage of the total dry weight of the
product. Any other substances should be specified in the technical data sheet.
The purity percentage is specified by mass fraction (kg/kg). When this is not possible according to the
3 3
state in which the product is presented, it can be expressed by volume fraction (m /m ) or cell fraction
(cell counts/all cell counts) or their corresponding concentrations if more appropriate.
The presence of GMO material in algae and algae products is to be considered as impurity (ref to EU Reg
on GMO).
The presence of not organ
...