EN ISO 29621:2017 PDF

Name: EN ISO 29621:2017 — Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)
SKU: EN ISO 29621:2017
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Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)

Название (английский):

EN ISO 29621:2017

Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 19
Дата публикации:: 29 марта 2017 г.
Издание:: CEN EN 29621 edition 2 version 1
ICS:: 07.100.40

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Описание (английский):

ISO 29621:2017 gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 29621:2017 (ISO 29621:2017) - "Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low‑risk products" - provides guidance to cosmetic manufacturers and regulatory bodies on how to perform a microbiological risk assessment to identify finished cosmetic products that, based on their characteristics, present a low risk of microbial contamination and therefore may not require routine application of microbiological International Standards or extensive microbial testing.

This standard replaces the 2011 edition and is a guidance document (no normative references). It clarifies when product features create a hostile environment for microorganisms and how those features should be evaluated in a risk‑based quality strategy.

Key topics and technical focus

Definition of microbiologically low‑risk products: products whose physical and chemical environment denies microorganisms the requirements for growth and/or survival.

Risk assessment framework: overall process including risk identification, analysis and evaluation to decide if microbiological standards apply.

Product composition factors:

Water activity (aw) - role of available water in supporting microbial metabolism and growth.
pH of formulation - influence on survival and proliferation.
Raw materials - ingredients that create hostile conditions (e.g., osmotic or chemical inhibitors).
Note: presence of preservatives alone does not automatically classify a product as low‑risk.

Production and packaging considerations: manufacturing conditions (GMP), packaging that prevents ingress of microorganisms, and how combined factors increase hostility to microbes.

Combined factors: how multiple sub‑lethal or lethal factors act together to inhibit growth or cause cell death.

Practical applications and users

Cosmetic manufacturers (R&D, QC, microbiology labs)

Regulatory authorities and notified bodies

Quality assurance managers and auditors

Contract manufacturers and formulators

How it’s used:

To determine whether a finished product requires routine microbiological testing or can be justified as low‑risk.

To inform product development decisions (formulation and ingredient selection) with microbiological safety in mind.

To define sampling and testing strategies within a risk‑based quality management system.

To support regulatory submissions and internal documentation demonstrating a reasoned microbiological risk assessment.

Related standards

ISO 22716 (Cosmetic GMP) - referenced for manufacturing controls

Cosmetic microbiology standards often considered alongside ISO 29621: ISO 18415, ISO 18416, ISO 22717, ISO 22718, ISO 21150

Keywords: EN ISO 29621:2017, ISO 29621:2017, cosmetics microbiology, microbiologically low‑risk products, microbial risk assessment, water activity, pH, cosmetic GMP.

EN ISO 29621:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical focus

Practical applications and users

Related standards

Технические детали

ISO 29621:2017

Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-ris…

SIST EN ISO 22716:2008

Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (ISO 22716:2007)

SIST EN ISO 29621:2017

Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-ris…

ISO 18415:2017/Amd 1:2022

Cosmetics — Microbiology — Detection of specified and non-specified microorganisms — Amendment 1

ISO 18416:2015/Amd 1:2022

Cosmetics — Microbiology — Detection of Candida albicans — Amendment 1

ISO 22717:2015/Amd 1:2022

Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa — Amendment 1

ISO 22718:2015/Amd 1:2022

Cosmetics — Microbiology — Detection of Staphylococcus aureus — Amendment 1

ISO 21150:2015/Amd 1:2022

Cosmetics — Microbiology — Detection of Escherichia coli — Amendment 1