EFfCI GMP FOR

COSMETIC
INGREDIENTS
Including the Certification Scheme for
GMP for Cosmetic Ingredients

REVISION 2017

Prepared by the European Federation

for Cosmetic Ingredients

In Collaboration with

Personal Care Products Council

Committed to Safety,
Quality & Innovation
All rights reserved. The EFfCI GMP Guide and Standard (this book) and its contents are
proprietary to EFfCI. This book may not be copied, reproduced or distributed in any form, or
used, referred to or modified, in part or in full, for any uses, including non-commercial uses,
without prior express permission from the publishers.

Copyright © 2005, 2008, 2010, 2012, 2017

European Federation for Cosmetic Ingredients
TABLE OF CONTENTS

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
0.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
0.2 Quality management principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
0.3 Process approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
0.4 Relationship with other management system standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2 Normative References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3 Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.1 Cosmetic ingredients (CI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4 Context of the Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.1 Understanding the organization and its context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.2 Understanding the needs and expectations of interested parties . . . . . . . . . . . . . . . . . . . . . 4
4.3 Determining the scope of the quality management system . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.4 Quality management system and its processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5 Leadership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.1 Leadership and commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2 Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.3 Organizational roles, responsibilities and authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6.1 Actions to address risks and opportunities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6.2 Quality objectives and planning to achieve them . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
6.3 Planning of changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7 Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.1 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.2 Competence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
7.3 Awareness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7.4 Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7.5 Documented information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

EFfCI GMP FOR COSMETIC INGREDIENTS 2017 • i

8 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.1 Operational planning and control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
8.2 Requirements for products and services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.3 Design and development of products and services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8.4 Control of externally provided processes, products and services . . . . . . . . . . . . . . . . . . . . 22
8.5 Production and service provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
8.6 Release of products and services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.7 Control of non-conforming outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
9 Performance Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
9.1 Monitoring, measurement, analysis and evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
9.2 Internal audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
9.3 Management review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
10 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
10.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
10.2 Nonconformity and corrective action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
10.3 Continual improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
APPENDIX A Definitions and Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
APPENDIX B References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
APPENDIX C Additional Sources of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
APPENDIX D EFfCI GMP Certification Scheme Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
APPENDIX E EFfCI GMP Certification Standard – Auditor
Competency and Training Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
APPENDIX F Clauses in Section 8 Which Are Not Applicable
to Distributors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
APPENDIX G Contributors to the EFfCI GMP Guide and Standard . . . . . . . . . . . . . . . . . . . . . . 53

ii • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
FOREWORD

The quality of cosmetic ingredients is critical to assure the safety, quality and efficacy of cosmetic prod-
ucts and related personal care products. Cosmetic ingredients have a wide range of applications and are
essential components of the cosmetic product formulation. Therefore, applying appropriate good manu-
facturing practice (GMP) principles to cosmetic ingredients is essential.

EFfCI is a European trade association representing the chemical and natural ingredient industries, the
suppliers and service providers for the cosmetic industries. EFfCI was set up in 2000 to represent the
collective interests of more than 100 cosmetic ingredient companies in Europe.

The idea underlying this definition of GMP for Cosmetic Ingredients is to provide manufacturers with a tool
for implementing an appropriate and workable GMP system.

The authors would very much appreciate comments as input in the further development of this document.

This is the fifth edition of this document.

The original document was issued in 2005 and updated in 2008 (when details of the certification scheme
and standard were added), aligned with ISO 9001:2008 in 2010 and comprehensively amended following
collaboration with the French cosmetic manufacturing association, FEBEA when the opportunity was tak-
en to introduce quality risk management approaches to aid the implementation of suitable GMP principles
to chemical synthesis and related manufacturing processes.

The inclusion of the Certification Scheme in 2008 allowed cosmetic ingredient suppliers to provide in-
dependent certification in order to show that their products have been prepared in accordance with the
EFfCI GMP Guide. Certification requires the supplier to hold a valid ISO 9001 Certificate which covers at
least all of the activities in the manufacture and supply of cosmetic ingredients.

In this version, there has been a comprehensive and complete review and revision of the Guide and Stan-
dard, including the alignment to ISO 9001:2015, a new side-by-side presentation of the GMP Guide and
Standard (“CI-GMP”) and a revision of all the Appendices. The previous Appendix D has been incorporated
into the main text.

In addition, this document has been revised in collaboration with a team of experts from the Personal
Care Products Council (PCPC) in order to ensure the GMP criteria are relevant globally.

This ensures that this edition of the GMP for cosmetic ingredients reflects the most recent version of
the standard ISO 9001 and provides the best basis for Certification to the GMP for Cosmetic Ingredients
worldwide.

Layout of the Document

The document incorporates existing GMP principles, WHO (World Health Organization) GMP Guidelines
for Excipients, IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients 2006, and
international quality management system requirements as developed by The International Organization
for Standardization (ISO).

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • iii
 Section 0 provides a general introduction to the document. Sections 1-10 provide guidance and standards
for compliance with relevant GMP principles and implementation of a quality management system. These
sections also recommend measures to limit cosmetic ingredient contamination. Individual manufacturers
should assess the GMP principles for suitability for application to their ingredients and, where justified,
take additional measures on a risk based approach.

The Appendices cover supporting guidance for the Auditor requirements, a glossary, references,
requirements for distributors of cosmetic ingredients and a list of contributing authors.

Recertification to the 2017 Version

Organizations holding certification to the 2012 edition of EFfCI GMP will need to align their quality man-
agement system to the 2017 edition of the EFfCI GMP standard and seek certification to it. Organizations
shall have until the end of 2018 to transition to this version of the GMP Guide and standard. From the 1st
January 2019 only a certificate to EFfCI GMP: 2017 will be valid.

This version of the EFfCI GMP Guide and Standard does not include any major changes to the require-
ments from the 2012 version. It is expected that a transition to the 2017 edition could be achieved in a
surveillance or a recertification audit.

2017 Version 2
This version of the 2017 edition has been reformatted to place the gudiance and standard in two side by
side columns and to correct a few small typographical errors. There is no content change over the first
version published in late 2017.

EFfCI – The European Federation for Cosmetic Ingredients aisbl

Head Office:
Avenue Louise 489
1050 Brussels
Belgium
Ent. No. 0840.955.059

For further information see www.EFfCI.com or contact EFfCI at [email protected]

iv • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
ACKNOWLEDGEMENTS

This guide was originally prepared by the EFfCI GMP Working group, who used, with permission, the draft
version of the IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006 as the
basis for a definition of Cosmetic Ingredient GMP.
We would like to thank IPEC-PQG for allowing us to use their guide in this way.

IPEC
The International Pharmaceutical Excipients Council (IPEC) is an international industry association,
formed in 1991 by manufacturers and end users of pharmaceutical excipients. It is an umbrella organi-
zation comprising three regional pharmaceutical excipient industry associations in the United States,
Europe, Japan, China and India (which are known collectively as the IPEC Federation). IPEC’s objective is
to contribute to the development and harmonization of international pharmaceutical excipient standards
and the development of good manufacturing practices for pharmaceutical excipients.

For further information, see www.ipec.org

PQG
The PQG was formed in 1977 to promote development of a consistent approach to pharmaceutical quality
and good manufacturing practice. PQG provides support to the pharmaceutical industry and its suppliers
with training, discussion meetings and certification standards and guidance. In 1990 the PQG published
three codes of practice to cover pharmaceutical raw materials, printed and contact packaging materials.
In 1995 the codes were revised and were integrated with ISO 9002:1994. The code for raw materials was
revised and reissued as PS 9100:2002 Pharmaceutical excipients, an application standard and GMP guide
for pharmaceutical excipients. Collaboration with IPEC led to the established and widely accepted IPEC/
PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, 2006.

For further information, visit www.pqg.org

FEBEA
The Fédération des Entreprises de la Beauté - French Federation of Fragrance, Cosmetics and Toiletries
(FEBEA) is a trade association for beauty and wellness companies (perfume, cosmetics, hygiene and per-
sonal care products, hair care), is made up of more than 300 companies. FEBEA has two central missions.
• Convince public authorities to implement the most favorable framework for the cosmetics indus-
try (lobbying),
• Assist (on a national and international scale) its members in developing their business to its full
potential (consulting).

PCPC
The Personal Care Products Council is the leading United States trade association representing the global
cosmetic and personal care products industry. Founded in 1894, the Council represents more than 600
member companies who manufacture, distribute, and supply the vast majority of finished personal care
products marketed in the U.S. The Council’s core mission is to create a productive business and regulatory
environment to enable the industry to create safe, quality and innovative consumer products. To carry out
its mission, the Council maintains three primary goals:
• Sound Science: Support the safety of products and ingredients through strong, science-based
programs.

EFfCI GMP FOR COSMETIC INGREDIENTS 2017 • v

 • Modernized Legislation: Advocate legislative and regulatory policy positions to support appro-
priate and coordinated regulation at the federal, state, and local levels
• Global Access: Ensure global market access for member companies by working towards harmo-
nization of regulation, reducing trade barriers, and influencing the global regulatory and trade
environment.

vi • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
Introduction

0.1 General
This document is intended to be a baseline guide that defines the extent and point of application of fundamen-
tal good manufacturing practice (GMP) principles for cosmetic ingredient manufacture. It covers the quality
management systems and the extent of GMP necessary throughout the manufacturing process. It is intended
to be used internationally to assist in determining whether the facilities and manufacturing controls used for
the production of cosmetic ingredients adequately ensure that they possess the quality, and purity which they
purport to possess, and that they are suitable for their intended use.

The text provides the guidance and standards necessary for manufacturing cosmetic ingredients but not all of
the details. As an international document for a wide range of personal care ingredients, it cannot specify all
national legal requirements or cover all particular characteristics of every cosmetic ingredient.

The quality management system standard chosen as a framework for this guide is ISO 9001:2015, which
is appropriate for manufacturing facilities. The headings in this document have been aligned with the ISO
9001:2015 numbering because many cosmetic ingredient manufacturers already use that standard as a basis
for their quality management system, including those companies that already have third party certification.
Additional headings or numbering lists are included as required to introduce the additional guidance on GMP,
where not covered by existing ISO 9001:2015 clauses. Text in italics is ISO 9001:2015 text.

This version of EFfCI GMP Guide:

• has highlighted the importance of risk assessments and has made ISO 9001:2015 requirements more
specific for cosmetic ingredient manufacturing sector;
• is more detailed with reference to the ‘Control of Changes’;
• has defined the obligation to establish an independent quality unit and its activities.

Beginning with Section 4, each clause in this document contains two sections and is presented in a two-column
format. The left column (CI-Guidance), is guidance on the GMPs, why they are needed and aids implementation
of these GMPs for cosmetic ingredients. The right column (CI-GMP Standard), is a standard and is the annex
to ISO 9001 detailing “what to do” which allows for objective auditing of the GMP and quality management
systems. The EFfCI GMP Standard includes additional requirements that support the application of GMP to the
manufacture and distribution of Cosmetic Ingredients over and above those defined for a quality management
system in ISO 9001:2015. Where the document indicates “no additional comments/requirements” then there
are no further aspects of the quality management system that have to be implemented for GMP over those
required by ISO 9001.

A manufacturer may apply the GMP standard with or without certification. However, GMP certification has the
benefit of providing assurance to customers that a manufacturer conforms to this quality management system
through independent verification. EFfCI believes that merging GMP principles for cosmetic ingredient manufac-
turing into the ISO 9001:2015 quality management system enhances not only the quality management, but an
organization’s operational procedures as well. Cosmetic product formulators worldwide have shown increasing
regard for compliance with ISO 9001:2015 as almost a necessary qualification for their suppliers. Obtaining
certification is however, a business decision and not a recommendation of this guide.

EFfCI GMP FOR COSMETIC INGREDIENTS 2017 • 1

 Organizations not choosing certification should perform a gap analysis on the standard and address any gaps. If
an organization desires to be certified, only those approved EFfCI Certifying Bodies which are listed on the EFfCI
website using auditors which have been trained in the EFfCI GMPs should be used.

0.1.1 Applying cosmetic ingredient GMP

Cosmetic ingredient manufacture shall be carried out in accordance with GMP concepts consistent with this
document.

When considering how to use this document, each manufacturer should consider how it might apply to their
products and processes. Since cosmetic ingredients are diverse, some principles of the document may not be
applicable to certain products and processes. Use of risk assessments can help determine applicabilities as
indicated in the text.

0.2 Quality management principles

The objective of cosmetic ingredient GMP is to ensure that the manufacture of cosmetic ingredients results in a
consistent material with the desired appropriate quality characteristics.

The emphasis of the GMP for cosmetic ingredients is to assure product integrity, consistency, avoid product con-
tamination, ensure that appropriate records are maintained, and confer traceability.

Judgement based on a thorough knowledge of the process and an understanding as to the intended use of the
product is required to determine at which processing step GMP should be implemented.

A risk based approach should be used to apply the GMP concepts in this document.

EFfCI GMP is based on and aligned with ISO 9001, and it must be remembered that when ISO 9001 discusses
“validation” this does not mean the same requirements as seen in pharmaceutical validation activities and
programmes. This aligns EFfCI GMPs with the international standards and regulations for cosmetics which do
not require validation.

0.3 Process approach

EFfCI GMP builds on all the key quality management principles in ISO 9001:2015. Those organizations who are
compliant with ISO 9001:2015 will find that it is simple to build in the additional requirements for the EFfCI GMPs.

0.3.1 General
No further comments

0.3.2 Plan Do Check Act Cycle

No further comments

0.3.3 Risk based thinking

The manufacture and distribution of cosmetic ingredients is a diverse activity. As a result it is not possible to
define a single set of rules which are applicable to all cosmetic ingredients. In such circumstances a risk based
approach is required in which the organization identifies the potential risks to cosmetic ingredient quality and
consumer safety and then takes measures to mitigate those risks. EFfCI GMP has several clauses which outline
a risk based approach is required.

2 • EFfCI GMP FOR COSMETIC INGREDIENTS 2017

 A suitable risk assessment could be in the form of a listing of identified threats with an assessment of the prob-
ability of realising those threats and the consequences those threats may have on cosmetic ingredient quality
and consumer safety. In determining the risks consideration should be given to existing mitigation measures as
well as any new ones identified by the risk analysis. Acceptance criteria for residual risks remaining after the
implementation of mitigation measures should be defined.

Risk based methods such as HACCP (Hazard Analysis and Critical Control Point), FMEA (Failure Modes and
Effect Analysis) etc. or a detailed process flow diagram may be used to identify the unit operations, required
equipment, stages at which various substances are added, key steps in the process, critical parameters (time,
temperature, pressure, etc.), and necessary monitoring points.

0.4 Relationship with other management system standards

The EFfCI GMP Guide and Standard is intended to be fully compatible with ISO 9001:2015 and the ISO high
level structure for management system standards (Annex SL).

1 Scope

This EFfCI GMP Guide and Standard is intended to be applicable to all cosmetic ingredient manufacturers and
distributors. Certification to the standard is recommended when an organization needs to demonstrate it has
implemented a suitable level of GMP for the manufacture and/or distribution of cosmetic ingredients.

Throughout this annex, references to “GMP for Cosmetic Ingredients” will be referred to as “GMP”.

2 Normative references

ISO 9001:2015 Quality Management Systems – Requirements.

3 Terms and definitions

See Appendix A for specific terms used in this document.

3.1 Cosmetic ingredients (CI)

Cosmetic ingredients are substances or preparations that are intentionally included in a cosmetic product.

EFfCI GMP FOR COSMETIC INGREDIENTS 2017 • 3

4 Context of the
organization

4.1 Understanding the organization

and its context
CI-Guidance CI-GMP Standard
The organization should understand and identify No additional requirements to ISO 9001.
the internal and external issues concerning cosmet-
ics and cosmetic ingredients and include these in
the design of its quality management and GMP sys-
tems. It should review these issues as they change
and make suitable amendments to incorporate any
changes (see Section 6.3, 8.5.6 and 9.3). In partic-
ular, organizations should monitor relevant legisla-
tion for potential changes governing the manufac-
ture and use of cosmetic ingredients.

4.2 Understanding the needs and

expectations of interested parties
CI-Guidance CI-GMP Standard
The organization should identify, monitor and Customers and the regulatory authorities who
review the interested parties and their relevant oversee cosmetics as well as consumers of cos-
requirements because these will aid in defining metics shall be evaluated as interested parties.
the scope of the quality management and GMP Changes to the interested parties and or their
systems, as well as identifying risks and opportu- requirements shall be monitored and reviewed
nities for the organization. Interested parties will (see Section 6.3, 8.5.6 and 9.3).
include customers and the regulatory authorities
who oversee cosmetics as well as the consumers
who will use the cosmetics.

4.3 Determining the scope of the

quality management system
CI-Guidance CI-GMP Standard
When considering how to use this document, each This Standard includes additional requirements
manufacturer should consider how it might apply to ISO 9001:2015 for certification purposes which
to their products and processes. The manufactur- allows organizations to demonstrate compliance
ing and other operations performed on cosmetic with GMP for Cosmetic Ingredients. The organiza-
ingredients are diverse; therefore, there is sig- tion shall apply all the requirements of the GMP
nificant diversity in the threats to the assurance Standard if they are applicable within the deter-
of cosmetic ingredient quality. Therefore, some mined scope of its GMP and quality management
principles in this document may not be applicable system. If any requirements are determined as
in all circumstances. However their applicability not applicable then they may only be omitted if
should be evaluated before any decision is made this does not adversely affect the quality of
not to implement them. the cosmetic ingredients. The scope of the

4 • EFfCI GMP FOR COSMETIC INGREDIENTS 2017

 The scope of the cosmetic ingredient GMPs should: organization’s GMP and quality management
• be completely covered by the scope of the ISO system shall:
9001 certification; • be completely covered by the scope of the
• include a list of facilities, services, product certified ISO 9001 quality management system;
groups or products; • include a list of activities, facilities, product
• be defined and controlled as documented groups or products;
information. • be defined and controlled as documented
information.
For organisations which only distribute cosmetic
ingredients, Appendix F provides a list of sections
of chapter 8 which are not applicable to their
operations.

4.4 Quality management system and

its processes
CI-Guidance CI-GMP Standard
Cosmetic ingredient manufacturers should estab- 4.4.1
lish, implement, maintain and continually improve The organization shall determine the processes
the GMP and quality management processes needed for the quality management system and their
required to assure cosmetic ingredient quality. The application throughout the organization, and shall:
GMP principles outlined in this document provide i) determine and apply the criteria and methods
a reasonable basis for the quality management needed for the fulfilment of the cosmetic in-
system used in the manufacture of cosmetic ingre- gredient GMP requirements and their effective
dients. implementation;
j) include all manufacturing, testing or other op-
Where manufacturing, testing or other operations erations that are required to control and affect
that could affect cosmetic ingredient quality are cosmetic ingredient quality;
outsourced, these activities should be identified k) for outsourced operations, ensure the relevant
in the cosmetic ingredient manufacturer’s quality cosmetic ingredient GMP requirements are
management system (See Section 8.4), and the applied (See Section 8.4).
cosmetic ingredient manufacturer should ensure
that the applicable GMP principles in accordance 4.4.2
with this Annex are applied to those operations. No additional requirements

5 Leadership

5.1 Leadership and commitment

5.1.1 General
CI-Guidance CI-GMP Standard
Top management should demonstrate the im- Top management shall demonstrate leadership
portance they place on meeting the needs of and commitment with respect to the quality man-
the interested parties, including complying with agement system by:
appropriate regulations and these GMP principles k) communicating the importance of GMP to the
defined herein. This should be accomplished organization and its inclusion in the quality
management system;

EFfCI GMP FOR COSMETIC INGREDIENTS 2017 • 5

 through the development of a quality policy and l) ensuring that GMP objectives are defined,
establishment of quality objectives. Where quality established and implemented;
objectives are set, adequate resources should be m) providing the resources needed to maintain
provided by top management and the progress the GMP quality management system and im-
towards these should be reviewed at planned plement GMP objectives.
intervals.

5.1.2 Customer focus

CI-Guidance CI-GMP Standard
It is the responsibility of top management to Top management shall demonstrate leadership
demonstrate leadership and commitment to and commitment with respect to customer focus
ensure there is a corporate emphasis on satisfying by ensuring that:
customer requirements and meeting the require- d) there is a corporate emphasis on meeting the
ments of GMP. requirements of GMP for cosmetic ingredients.

5.2 Policy
5.2.1 Establishing the quality policy
CI-Guidance CI-GMP Standard
Top management should demonstrate its commit- Top management shall establish, implement and
ment to the corporate GMP and quality policy and maintain a quality policy that:
ensure that it is implemented within the oper- e) includes a commitment to the implementation
ational unit. The GMP and quality policy should of GMP for cosmetic ingredients;
support continual improvement of the quality f) provides a framework for setting quality
management system with regular review. Manage- objectives, including objectives for adherence
ment should participate in the development of the to GMP;
company’s GMP and quality policy and provide the g) defines where the GMP as defined in this
resources necessary for its development, mainte- Standard will be used in the organization.
nance, and deployment. Note: the “applicable requirements” in ISO
9001:2015 bullet c) includes GMP for cosmetic
ingredients

5.2.2 Communicating the quality policy

CI-Guidance CI-GMP Standard
The requirements for GMP should be communi- No additional requirements to ISO 9001:2015.
cated throughout the organization along with the
quality policy.

5.3 Organizational roles,

responsibilities and authorities
CI-Guidance CI-GMP Standard
Roles, responsibilities and authorities should be Responsibility and authority shall be defined by
clearly defined by top management and commu- top management and communicated within the
nicated within the organization. In particular, the organization; in particular the responsibility shall be
responsibility should be defined for ensuring that defined for ensuring that the GMP for cosmetic in-
the GMPs for cosmetic ingredients are communi- gredients are communicated, understood, reported
cated, understood, reported and integrated into and integrated into the quality management system.
the quality management system.

6 • EFfCI GMP FOR COSMETIC INGREDIENTS 2017

An independent Quality Unit should be estab- Top management shall establish an independent
lished to ensure freedom from conflicts of in- Quality Unit. The independence of the Quality
terest. The Quality Unit should ensure activities Unit shall be documented and demonstrated by
are identified and undertaken as defined and in showing the inter-departmental relationships as
accordance with the GMPs in this document and well as the relationship to top management.
the associated risk assessments. The Quality Unit
should participate in the investigation of critical The Quality Unit shall ensure that activities are
deficiencies. conducted in accordance with the GMPs in this
document and the associated risk assessments.
The independence of the Quality Unit should be The Quality Unit shall participate in the investiga-
documented and demonstrated by showing the tion of critical deficiencies.
inter-departmental relationships as well as the
relationship to top management. It is the Quality Top management shall ensure the following re-
Unit’s responsibility to maintain the quality man- sponsibilities are assigned and defined:
agement system. • performing the risk assessments required by
these GMPs;
Note: The Quality Unit may comprise Quality As- • approving suppliers of quality critical materials
surance and/or Quality Control functions. and services;
• approving or rejecting raw materials, packag-
Top management should assign an individual (or ing components, intermediates and finished
individuals) with the following defined responsibil- cosmetic ingredients;
ities that are critical to cosmetic ingredient quality • reviewing records to ensure that no critical er-
and the assurance of consumer safety: rors have occurred or, if these occur, that they
• performing the risk assessments required by are fully investigated;
these GMPs; • participating in authorizing changes to process-
• approving suppliers of quality critical materials es, specifications, procedures, test methods
and services; and investigating failures and complaints;
• approving or rejecting raw materials, packag- • approving or rejecting of the cosmetic ingredi-
ing components, intermediates and finished ent if it is manufactured, processed, packaged,
cosmetic ingredients; or held under contract by another company;
• reviewing records to ensure that no critical er- • training personnel in GMPs;
rors have occurred or, if these occur, that they • other tasks that may be critical to the manufac-
are fully investigated; ture of the cosmetic ingredient.
• participating in authorizing changes to process-
es, specifications, procedures, test methods Internal audits shall verify that these responsibili-
and investigating failures and complaints; ties have been undertaken as defined (see section
• approving or rejecting of the cosmetic ingredient 9.2).
if it is manufactured, processed, packaged, or
held under contract by another company; Personnel whose role is critical to ensuring cos-
• training personnel in the GMPs; metic ingredient quality shall have written job
• preparation of Certificates of Analysis (see Sec- descriptions.
tion 8.6.5);
• other tasks that may be critical to the manufac-
ture of the cosmetic ingredient.

Internal audits should verify that these respon-

sibilities have been undertaken as defined (see
Section 9.2).

Personnel whose role has an impact on cosmetic in-

gredient quality should have written job descriptions.

EFfCI GMP FOR COSMETIC INGREDIENTS 2017 • 7

6 Planning

6.1 Actions to address risks and

opportunities
CI-Guidance CI-GMP Standard
The organization should conduct and record The organization shall conduct and record risk as-
risk assessments (see Section 0.3.3.) related to sessments as required in the other sections of this
cosmetic ingredient quality and consumer safety standard. Where existing controls to minimize the
based on the context of the organization (see risks to cosmetic ingredient quality are not consid-
Section 4.1 and 4.2). The use of risk assessments ered effective then additional measures shall be
is indicated in the remaining sections of this Guide implemented and these measures documented in
and includes: the quality management system.
6.3 Planning of Changes
7.1.3 Infrastructure Risk assessments shall be reviewed and revised
7.1.4 Environment for the operating of pro- in the event of non-conformity of the product or
cesses relevant aspect of the quality management sys-
8.5.1.2 Equipment Cleaning tem. Additional measures shall be implemented as
8.4.1 Control of externally provided processes, identified.
products and services - general
8.5.4.2 Packaging Systems
8.7.1 Reprocessing/Reworking

Where existing controls to minimize the risks to cos-

metic ingredient quality are not considered effective
then additional measures should be implemented
and documented in the quality management system.
The effectiveness of these actions should be evalu-
ated.

A suitable risk assessment could be in the form of

a listing of identified threats with an assessment
of the probability of realising those threats and
the consequences those threats may have on
cosmetic ingredient quality and consumer safety.
In determining the residual risks consideration
should be given to existing mitigation measures as
well as any new ones identified by the risk analy-
sis. Acceptance criteria for residual risks should be
defined.

Risk assessments should be reviewed and revised

in the event of non-conformity of the product or
relevant aspect of the quality management sys-
tem. Additional measures should be implemented
as identified.

8 • EFfCI GMP FOR COSMETIC INGREDIENTS 2017

6.2 Quality objectives and planning to
achieve them
CI-Guidance CI-GMP Standard
Top management should set objectives for Top management shall set objectives to maintain
adherence to GMP to ensure that the cosmetic and improve compliance to GMP.
ingredient manufacturer maintains and improves
its performance. Objectives should be deployed
throughout the organization, be measurable and
consistent with the quality policy, and have a
periodic review.

6.3 Planning of changes

CI-Guidance CI-GMP Standard
There should be a documented procedure defining There shall be a documented procedure defining
the responsibilities and requirements for the eval- the responsibilities and requirements for the eval-
uation and approval of changes that may impact uation and approval of changes that may impact
the quality management system. the quality management system. Evaluation and
approval of changes shall occur prior to the imple-
There should be consideration given to the impact mentation. Records of the change control process
any changes made have on related activities and shall be retained.
procedures. A defined plan of actions commen-
surate with the risks should be developed for the
change.

Evaluation and approval of changes should occur

prior to their implementation. Records of the
change control process, action plans and their
implementation should be retained.

Note: See also Section 8.5.6.

7 Support

7.1 Resources
Resource requirements to meet the requirements
of this Guide should be identified. A gap analysis
based on this guide as well as internal audits can
be used for this purpose.

EFfCI GMP FOR COSMETIC INGREDIENTS 2017 • 9

 7.1.1 General
CI-Guidance CI-GMP Standard
Top management should provide sufficient The organization shall consider the
resources (e.g., people, equipment, materials, c) GMP requirements of this standard.
buildings and facilities) to implement, maintain
and improve the quality management system and
to manufacture, package, test, store and release
each cosmetic ingredient in a manner consistent
with this guide.

7.1.2 People
CI-Guidance CI-GMP Standard
Top management should determine and provide The organization shall determine and provide the
sufficient people to implement, maintain and persons necessary for the effective implementa-
improve the quality management system and to tion of GMP.
manufacture, package, test, store and release
each cosmetic ingredient in a manner consistent
with this guide (see also Section 7.2).

7.1.3 Infrastructure
CI-Guidance CI-GMP Standard
The organization should provide and maintain The infrastructure shall be managed, operated,
the infrastructure required to avoid raw material, cleaned and maintained to avoid raw material,
intermediate and cosmetic ingredient contamina- intermediate and cosmetic ingredient contamina-
tion (including control of particulate matter, pro- tion (including control of particulate matter, mi-
cessing materials and aids, microbiological control crobiological control and control of water quality
and control of water quality where applicable). where applicable).

The organization should conduct and record a risk The organization shall conduct and record a risk
assessment based on the organization’s intended assessment based on the organization’s intended
use of the infrastructure to identify areas in which use of the infrastructure to identify areas in which
the cosmetic ingredient is at risk for contamina- the cosmetic ingredient is at risk for contamina-
tion from deficiencies in buildings and/or facilities. tion from deficiencies in buildings and/or facilities.
The risk assessment should consider the following The risk assessment shall consider the following at
at a minimum: a minimum to identify where the cosmetic ingredi-
ent is at risk from contamination:
a) location of the operations (e.g. internal,
external); a) location of the operations (e.g. internal, external);
b) state of repair of the building and facility; b) state of repair of the building facility;
c) suitable size, construction and location; c) equipment construction and location;
d) ability to maintain a suitably clean building and d) ability to maintain a suitably clean building and
facility environment; facility environment;
e) operations that can affect the cosmetic e) operations that can affect the cosmetic
ingredient quality; ingredient quality;
f) presence of airborne contaminants, especially f) presence of airborne contaminants, especially
highly sensitizing or toxic substances. highly sensitizing or toxic substances.

10 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
Where existing controls to minimize the risks of Where existing controls to minimize the risks of
cosmetic ingredient contamination are not con- cosmetic ingredient contamination are not consid-
sidered effective then additional measures should ered effective then additional measures shall be
implemented and these measures documented in documented and implemented.
the quality management system.
Only authorised users shall have access to com-
The following subsections provide more detailed puter systems which are critical to the assurance
guidance on the specific aspects related to infra- of cosmetic ingredient quality.
structure.

7.1.3.1 Buildings and facilities

Buildings and facilities used in the manufac-
ture, processing, packaging, testing, or storage
of a cosmetic ingredient should be maintained
in a good state of repair and should be of
suitable size, construction, and location to
facilitate cleaning, maintenance, and correct
operation. The prevention of cross contami-
nation should be considered in the design and
operation of the manufacturing processes and
facilities.

There should be adequate facilities for the

testing of raw materials, packaging compo-
nents, intermediates, and finished cosmetic
ingredients.

7.1.3.2 Equipment
Equipment used in the manufacture,
processing, packaging, testing, or storage of a
cosmetic ingredient should be maintained in a
good state of repair and should be of suitable
size, construction, and location to facilitate
cleaning, maintenance, and correct operation.

Where equipment is located outdoors there

should be suitable controls to minimise the risk
to the cosmetic ingredient from the environ-
ment (e.g. processing within a closed system).

7.1.3.2.1 Equipment construction

Process equipment should be constructed
so that contact surfaces will not be reactive,
additive, or absorptive and thus not alter the
quality of the cosmetic ingredient. Substances
required for operation, such as lubricants or
coolants, should not come into contact with
raw materials, packaging materials, interme-
diates, or finished cosmetic ingredients unless
technically unavoidable. Exposure of the

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 11
 cosmetic ingredient to extraneous materials
(such as additives, lubricants, etc.) that are
not part of the formulation should be avoided.
Where exposure is not technically avoidable,
the substances should be compatible with use
in cosmetic ingredients.

Equipment should be designed to minimize the

possibility of contamination caused by direct
operator contact.

7.1.3.2.2 Equipment maintenance

Written procedures should be established and
followed for maintenance of critical equipment
used in the manufacture, processing, packaging,
testing or, holding of the cosmetic ingredient.
There should be records of the use and main-
tenance of quality critical equipment. These
records can be in the form of a log, computer
database, or other appropriate documentation.

7.1.3.2.3 Computer systems

Computer systems used in the manufacturing
and/or testing of cosmetic ingredients should
have sufficient controls for operation, mainte-
nance and prevention of unauthorized access or
changes to data software and computer hard-
ware.

The following controls should be established:

• only authorised users should have access to
the computer systems;
• retention of suitable back-up systems such as
copies of the programs and files;
• assurance that changes are verified and
documented, and only made by designated
personnel. Electronic data used as a record
should meet the requirements for the control
of records (see Section 7.5.3.2).

7.1.3.3 Utilities used in manufacture

of cosmetic ingredients
Utilities (e.g. nitrogen, compressed air, steam
etc.) used in the manufacture of cosmetic ingre-
dients that could impact upon product quality
should be assessed and appropriate action taken
to control the risk.

12 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
7.1.3.4 Water used in manufacture
of cosmetic ingredients
Water that comes into direct contact with the
cosmetic ingredient during manufacture or re-
mains in the final product should be suitable for
its intended use.

Unless otherwise justified, water that comes

into direct contact with the cosmetic ingredi-
ent should, at a minimum, meet World Health
Organization (WHO) guidelines for drinking
(potable) water quality. If drinking (potable)
water is insufficient to assure quality, and tighter
chemical and/or microbiological water quality
specifications are required, appropriate specifi-
cations should be set, e.g. physical and chemical
attributes, total microbial counts and objection-
able organisms.

Where water used in the process is treated by

the manufacturer to achieve a defined quality,
the treatment process should be specified and
monitored with appropriate action limits.

7.1.4 Environment for the operating

of processes
CI-Guidance CI-GMP Standard
The work environment should be managed and The work environment shall be managed to mini-
controlled to minimize risks of cosmetic ingredient mize risks of cosmetic ingredient contamination. A
contamination. A documented risk assessment documented risk assessment shall be carried out
should be carried out and recorded to determine to determine the necessary controls.
the necessary controls.
The documented risk assessment shall cover the
The documented risk assessment should cover the following controls, as applicable:
following controls, as applicable: a) air handling systems;
a) air handling systems (e.g. Heating, Ventilation b) special environments;
and Air Conditioning (HVAC) systems); c) cleanliness and sanitary conditions;
b) special environments; d) waste segregation and disposal;
c) cleanliness and sanitary conditions; e) pest control;
d) waste segregation and disposal; f) other risk assessments required by this
e) pest control; Standard.
f) other environmental factors that could impact
cosmetic ingredient quality (e.g. Building Where maintenance of the work environment is
Management Systems); critical to cosmetic ingredient quality, the controls
g) other risk assessments required by this shall be documented.
document.

Where maintenance of the work environment is

critical to ensure cosmetic ingredient quality, the
controls should be documented in the quality man-
agement system and suitable records retained.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 13
 The following subsections provide more detailed
guidance on the specific areas evaluated in the
risk assessment and should be adopted where the
risk assessment has identified these controls are
necessary.

7.1.4.1 Cleaning
Adequate cleanliness is an important consider-
ation in the design and operation of cosmetic
ingredient manufacturing facilities. Buildings
used in the manufacture, processing, packaging,
or holding of a cosmetic ingredient should be
maintained in an appropriately clean condition.

Where maintenance of clean and sanitary con-

ditions is critical to cosmetic ingredient quality,
written procedures should assign responsibility
for cleaning and describe in sufficient detail the
schedules, methods, equipment, and materials
to be used in cleaning the buildings and facilities.
These procedures should be followed and clean-
ing should be documented. Cleaning procedures
should be verified to be appropriate for the
surface being cleaned.

Waste should be segregated, held and disposed

of in a timely and appropriate manner.

7.1.4.2 Pest Control

A risk assessment should be completed to de-
termine the need for pest control and the extent
of any implemented programme. It should also
include an assessment of the chemicals used in
the programme and the threats these may pose to
cosmetic ingredient quality. Where the cosmetic
ingredient is at risk of contamination from pests
then buildings should be free of infestation by
rodents, birds, insects, and other vermin.

Some starting materials, particularly botanicals,

may contain some unavoidable contamination,
such as rodent or other animal filth or infesta-
tion. Control methods should be identified to
prevent the increase of contamination or infesta-
tion in holding areas, or its spread to other areas
of the plant.

14 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
7.1.4.3 Lighting
Adequate light should be provided in all areas
to facilitate cleaning, maintenance, operations
and testing. The hazards posed from glass
lighting components should be included in the
work environment risk assessment.

7.1.4.4 Drainage
In areas where the cosmetic ingredient is open
to the environment, drains should be of ade-
quate size and, where connected directly to a
sewer, should be provided with an air break
or other mechanical device to prevent back
siphoning.

7.1.4.5 Personnel hygiene

Where cosmetic ingredients are exposed to the
environment, personnel should wear protective
apparel such as head, face, hand, arm coverings as
necessary. Jewellery and other loose items should
be removed or covered to protect the cosmetic
ingredient.

Personnel should practice good sanitation and

health habits.

The storage and use of food, drink, tobacco

products or similar items should be restricted
to certain designated locations separate from
manufacturing areas.

7.1.4.6 Washing and toilet facilities

Adequate washing facilities, including hot and
cold water, soap or detergent, air dryers or
single service towels, and clean toilet facilities
should be provided. These should be easily ac-
cessible from working areas. Washing facilities
should not pose a threat to cosmetic ingredient
quality. Adequate facilities for showering and/
or changing clothes should be provided, where
appropriate.

7.1.5 Monitoring and measuring

resources
7.1.5.1 General
CI-Guidance CI-GMP Standard
Monitoring and measurement resources should be No additional requirements to ISO 9001:2015.
suitable for the evaluation of cosmetic ingredients.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 15
 7.1.5.2 Measurement traceability
CI-Guidance CI-GMP Standard
Measuring and test equipment, including com- No additional requirements to ISO 9001:2015.
puter software, identified as being critical parts
of the quality management system, should be
properly calibrated and maintained. This includes
all inprocess instruments identified as quality
management system instruments, as well as test
equipment used in the laboratory. The control
program should include the standardization or cal-
ibration of quality critical instruments and equip-
ment at suitable intervals in accordance with an
established written program. This program should
contain specific directions, schedules, limits for
accuracy and precision as appropriate, and provi-
sions for remedial action in the event that accura-
cy and/or precision limits are not met. Calibration
standards should be traceable to recognised
national or compendial standards as appropriate.

Instruments and equipment not meeting estab-

lished specifications should not be used and an
investigation should be conducted to determine
the validity of the previous results since the last
successful calibration. The current calibration sta-
tus of quality critical instruments and equipment
should be known and verifiable to users.

7.1.6 Organizational knowledge

CI-Guidance CI-GMP Standard
The organization should have current knowledge No additional requirements to ISO 9001:2015.
of the cosmetic industry, its regulatory require-
ments, customer and consumer expectations and
GMP for cosmetic ingredients. This knowledge
should be made available to the extent necessary
for personnel to perform their duties and ensure
the quality and safety or integrity of the cosmetic
ingredient.

Note: Participation in EFfCI activities provides an

excellent means of gaining this knowledge.

7.2 Competence
CI-Guidance CI-GMP Standard
Personnel performing work affecting the quality of The organization shall:
cosmetic ingredients should have the appropriate e) perform refresher training on GMP and
education, training and/or experience for their personal hygiene at defined intervals to ensure
assigned tasks. Job descriptions should include the that employees remain familiar with applicable
competencies required for the duties performed. GMP principles.

16 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
 The cosmetic ingredient manufacturer should
establish and maintain procedures for identifying
training needs and providing the necessary train-
ing to all personnel performing activities affecting
cosmetic ingredient quality. Appropriate records
of training should be maintained. Training should
be in the particular operations that the employ-
ee performs and in GMP as they relate to the
employee’s functions. The effectiveness of GMP
training should be evaluated. GMP training should
be revised and redelivered as changes occur to
customer and regulatory requirements as well as
the activities affecting cosmetic ingredient quality.

GMP training on this guideline should be con-

ducted with sufficient frequency to ensure that
employees remain familiar with applicable GMP
principles. Management should establish ade-
quate and recurring personal hygiene training
for all personnel handling materials so that they
understand the precautions necessary to prevent
contamination of cosmetic ingredients.

7.3 Awareness
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should No additional requirements to ISO 9001:2015.
ensure there is a good awareness of GMP, the im-
portance of ingredient quality to the final cosmetic
and any consequences to consumer safety of not
following these requirements and the organiza-
tions procedures.

7.4 Communication
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should en- GMP and regulatory requirements shall be com-
sure that appropriate processes are established to municated as appropriate throughout the organi-
communicate GMP and regulatory requirements, zation.
quality policies, quality objectives and procedures
throughout the organization. The communication Top management shall be notified in a timely man-
should also provide information about the effec- ner of quality critical situations, such as recall or
tiveness of the quality management system. withdrawal of cosmetic ingredients, in accordance
with a documented procedure.
Top management should be notified in a timely
manner of quality critical situations, such as recall
or withdrawal of cosmetic ingredients, in accor-
dance with a documented procedure.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 17
7.5 Documented information
7.5.1 General
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should No additional requirements to ISO 9001:2015.
have a system to control documented information
and ensure the integrity of procedures, records
and data related to the requirements of the quali-
ty management system.

7.5.2 Creating and updating

7.5.2.1 Creating and updating documents
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should Documents that impact product quality shall be
establish and maintain procedures for the identi- reviewed and approved by the Quality Unit.
fication, collection, indexing, filing, and storage of
controlled documents, including documents of ex- The retention period of obsolete documents shall
ternal origin that are part of the quality manage- be defined. The Quality Unit shall securely retain
ment system. In addition, the procedures should at least one copy of obsolete documents.
include the processes for approval, revision, and
distribution of controlled documents. If electronic signatures are used on documents
they shall be controlled to provide equivalent se-
Documents and subsequent changes to doc- curity to that given by a hand written signature.
uments should be reviewed and approved by
designated personnel before issuance to the
appropriate areas as identified in the documents.
Documents that impact product quality should be
reviewed and approved by the Quality Unit.

Controlled documents should include a unique

identifier, date of issue, and a revision number to
facilitate identification of the most recent docu-
ment. Changes and the reasons for the change
should be documented.

The retention period of obsolete documents

should be defined, after which period they could
be discarded The Quality Unit should securely re-
tain a copy of obsolete documents to aid traceabil-
ity and investigations.

Electronic documentation should meet the

requirements for the document control system
stated above. If electronic signatures are used on
documents, they should provide the same degree
of security as to that given by a hand written
signature.

18 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
7.5.2.2 Creating and updating records
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should Entries in quality records shall be clear, indelible
establish and maintain procedures for the iden- and made directly after performing the activity
tification, collection, indexing, filing, storage and (in the order performed). Quality records and any
maintenance of quality records. These records corrections made to them shall be traceable.
can be in the form of a log, computer database, or
other appropriate documentation.

Quality records should be legible and traceable

to the product involved. Pertinent subcontrac-
tor quality data should be an element of these
records.

Entries in quality records shall be clear, indelible

and made directly after performing the activity
(in the order performed). Quality records and any
corrections made to them shall be traceable.

7.5.3 Control of documented

information
7.5.3.1
CI-Guidance CI-GMP Standard
Controls should provide assurance that the rele- No additional requirements to ISO 9001:2015.
vant version of a procedure is being used through-
out the operation and that previous revisions of
documents are removed from use.

7.5.3.2
CI-Guidance CI-GMP Standard
Quality records should be maintained to demon- Quality records shall be kept for a defined period.
strate achievement of the required quality and the The period shall be justified. For batch records,
effective operation of the quality management this period shall not be less than one year past
system. the cosmetic ingredient expiry or original retest
interval.
Quality records should be kept for a defined peri-
od. This interval should be justified based on the
nature of the cosmetic ingredient, and the knowl-
edge of its stability. The retention period for batch
records should be at least one year more than the
cosmetic ingredient’s expiry date or original retest
interval. Quality records should be stored and
maintained in such a manner that they are readily
retrievable and in facilities that provide a suitable
environment to minimize deterioration or dam-
age. These controls should be applied to ensure
the integrity of data when it is used as a quality
record (see also Section 7.1.3.2.3).

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 19
8 OPERATION

8.1 Operational planning and control

CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should plan The organization shall plan, implement and control
and develop the processes and controls needed the processes (see Section 4.4) needed to meet
for product manufacture. the requirements for the provision of products and
services, and to implement the actions determined
These plans and controls should be appropriate to in clause 6 by:
the process, cosmetic ingredient specification, the f) written testing programs for cosmetic
risks identified in Sections 7.1.3. and 7.1.4, and ingredients that include specifications, sampling
the equipment and facilities used in the manufac- plans, test and release procedures;
ture of the product. g) defined testing or other appropriate controls
for quality critical materials;
Key aspects of the planning of suitable process h) environmental, contamination and hygiene
and controls should include as appropriate: control programs;
• written testing programs for quality critical i) requiring that contract manufacturers or
materials and the cosmetic ingredients that laboratories adhere to the relevant sections of
include appropriate specifications, sampling this Standard.
plans, test and release procedures;
• the generation and maintenance of records
(see Section 7.5.2, 7.5.3) that provide evidence
that these plans have been realised as intended
and enables traceability to be demonstrated
(see Section 8.5.2);
• provision of resources to realise these plans,
• environmental, contamination and hygiene
control programs;
• that in-process samples should not be returned
to production for incorporation into the final
batch unless appropriate authorisation from
the quality unit has been received.

If activities relating to cosmetic ingredient man-

ufacture are outsourced, the organization should
ensure their service provider addresses the appli-
cable aspects of planning and controls in accor-
dance with this Standard (see Section 8.4).

8.2 Requirements for products

and services
8.2.1 Customer communication
CI-Guidance CI-GMP Standard
There should be provision for providing accurate The organization shall determine and implement
and pertinent communication to the customer. effective arrangements for communicating with
Provision should be made for replying to customer customers in relation to:
inquiries, contracts, and order handling. Customer f) Significant changes (see Section 8.5.6).

20 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
 feedback and complaints should be documented.
Customers should be notified of significant changes
(see Section 8.5.6).

8.2.2 Determination of requirements

for products and services
CI-Guidance CI-GMP Standard
The requirements of the customer should be No additional requirements to ISO 9001:2015.
identified, including regulatory requirements. The
regulatory requirements applicable to the prod-
ucts for their intended use as cosmetic ingredients
should be incorporated into the quality manage-
ment system. Other requirements not stated by
the customer but necessary for specified or in-
tended use, where known, should be considered.
Organizations should monitor relevant legislation
for potential changes governing the manufacture
and use of cosmetic ingredients.

8.2.3 Review of the requirements for

products and services
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer and cus- No additional requirements to ISO 9001:2015.
tomer should mutually agree upon the require-
ments identified in Section 8.2.2 before supply
commences. The manufacturer should have the
facility and process capability to consistently meet
the mutually agreed upon cosmetic ingredient
specifications.

8.2.4 Changes to requirements for

products and services
CI-Guidance CI-GMP Standard
Where the requirements determined in Section No additional requirements to ISO 9001:2015.
8.2.2 are changed, this review should be repeat-
ed before supply recommences (see also Section
8.5.6).

8.3 Design and development of

products and services
CI-Guidance CI-GMP Standard
ISO 9001:2015 includes requirements for ensuring The organization shall demonstrate how cosmetic
control over design and development activities. ingredient GMP requirements have been applied
Companies involved in such activities are by the time a new cosmetic ingredient is trans-
recommended to follow the requirements of ISO ferred into production.
9001:2015. GMP is not always applicable during
the design and development of new cosmetic
ingredients; however, the GMP defined in this
guide should be applied by the time a

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 21
 new cosmetic ingredient is commercialised.
The applicable GMP requirements should be
considered during the design and development
phases of cosmetic ingredients to ensure that the
processes used will be adequate upon transfer to
manufacturing.

8.4 Control of externally provided

processes, products and services
8.4.1 General
CI-Guidance CI-GMP Standard
Manufacturers of cosmetic ingredients should No additional requirements to ISO 9001:2015.
have a system for selecting suppliers of quality
critical materials and services including subcon-
tract manufacturers and laboratories (see Section
4.4.). This should require an evaluation including
adequate evidence that the supplier can con-
sistently meet agreed requirements. Records of
these activities should be maintained.

Materials should be purchased against an agreed

specification from approved suppliers.

When outsourcing the manufacture of cosmetic

ingredients under the scope of the EFfCI cosmetic
GMP standard, the organization should implement
controls using a risk based approach to ensure
that the processes used comply with EFfCI GMPs.

8.4.2 Type and extent of control

CI-Guidance CI-GMP Standard
There should be procedures for the approval and Activities to verify the purchased product shall use
release of each raw material used in the produc- procedures designed to prevent contamination of
tion of cosmetic ingredients. Upon each receipt, the material.
raw materials should not be used prior to accep-
tance. Where materials are supplied continuously
via pipelines, the cosmetic ingredient manufactur-
er should establish an agreement with the suppli-
er so that they are notified of material that does
not meet specification.

Raw material approval checks should include

a supplier certificate of analysis and wherever
feasible, at least an identification test. Testing
schedules should be organised to separate those
tests that are routine from those that are per-
formed infrequently or only for new suppliers. If
raw materials are not sampled and tested, they
should have alternative controls in place to assure
their quality.

22 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
 Sampling activities should be conducted under
defined conditions, in accordance with a sampling
method, using procedures designed to prevent
contamination of the raw material.

Deliveries made by bulk tankers should have

defined controls based on the risks to raw mate-
rial quality to assure material purity and freedom
from contamination (for example, dedicated tank-
ers, seals, a certificate of cleaning which indicates
the previous load, analytical testing, audit of the
supplier, etc.).

These processes, activities and results should be

documented and records maintained.

8.4.3 Information for external

providers
CI-Guidance CI-GMP Standard
Purchasing agreements should contain data clearly No additional requirements to ISO 9001:2015.
describing the material or service ordered, includ-
ing, where applicable, the following:
• The need to comply with the appropriate
sections of this guide for any relevant contract
manufacturers or laboratories;
• a requirement to notify the cosmetic ingredient
manufacturer of significant changes in quality
critical raw materials.

8.5 Production and service provision

8.5.1 Control of production and
service provision
CI-Guidance CI-GMP Standard
Production activities should be carried out under Controlled conditions shall include, as applicable:
controlled conditions (see Section 8.1). i) Production instructions and records;
j) Equipment cleaning;
Specific examples of controls that are important k) Recovery of solvents and similar activities;
are illustrated in the following sections. Not all of l) In-process mixing and blending;
these may be applicable to all cosmetic ingredient m) In-process control;
manufacturers. n) Packaging and labelling;
o) Records of equipment use.

The organization shall identify the need for and

justify equipment cleaning and where used,
sanitization procedures and provide evidence of
their effectiveness. The effectiveness of cleaning
procedures shall be re-evaluated after significant
changes.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 23
 8.5.1.1 Production instructions and records
Production instructions and records are required
but may differ for the type of operation, for
example batch versus continuous.

Production instructions should be prepared for

each cosmetic ingredient to be manufactured. An
accurate reproduction of the master production
instructions should be issued to the production
area.

Where manufacturing processes run entirely on

automation and are controlled by having specific
settings on the process control computer then
there should be a defined and restricted access
to changing those settings.

Records should be available for each batch

of cosmetic ingredient produced and should
include information relating to the production
and control of each batch, including continuous
processes. Records may be in different locations
but should be readily retrievable.

Records should include, where critical to cosmet-

ic ingredient quality, documentation that each
significant step in the manufacture, processing,
packing, or holding of the batch has been accom-
plished, for example:
• date/time each step was completed;
• identification of individual major equipment
and lines used;
• specific identification of each batch of compo-
nent or inprocess material used;
• weights and measures of components used in
the course of processing;
• in-process and laboratory control results;
• a record of the inspection of the packaging and
labelling area before and after use;
• a recorded statement of the actual yield or
quantity produced and a statement of the per-
centage of theoretical yield;
• labelling control records;
• description of cosmetic ingredient product
containers and closures;
• description of sampling performed;
• identification of persons performing or super-
vising the operations or checking each signifi-
cant step in the operation;
• a record of investigations made for failures and
discrepancies;
• results of final product inspection.

24 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
8.5.1.2 Equipment cleaning
A risk assessment should be used to identi-
fy the need for equipment cleaning and/or
sanitisation procedures. Where required, these
procedures should be documented and contain
sufficient details to allow operators to clean
each type of equipment in a reproducible and
effective manner. Evidence of the effectiveness
of such cleaning and/or sanitisation procedures
should be available. The effectiveness of clean-
ing procedures should be re-evaluated after
significant changes.

Equipment and utensils should be cleaned,

where critical to cosmetic ingredient quality, at
appropriate intervals to prevent contamination
of the cosmetic ingredient. The cleaning
status of equipment should be recorded
appropriately.

Where multipurpose equipment is in use, it is

important to be able to determine previous
usage when investigating crosscontamination
or the possibility of such contamination (see
Section 8.5.1.7).

During a production campaign, incidental carry-

over frequently occurs and usually is acceptable
since clean-up between successive batches of
the same cosmetic ingredient is not normally
required to maintain quality levels.

For continuous processing the frequency of

equipment cleaning should be determined by
the manufacturer and justified.

8.5.1.3 Recovery of solvents, mother

liquors and second crop crystallizations
Where solvents are recovered and reused in the
same process or different processes they should
meet defined quality standards prior to reuse or
mixing with other approved material.

Mother liquors or filtrates containing recover-

able amounts of cosmetic ingredient, reac-
tants, or intermediates are frequently reused.
They should meet defined quality standards
prior to reuse or mixing with other approved
material. Such processes should be document-
ed in the batch production records to enable
traceability.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 25
 8.5.1.4 In-process blending/mixing
In-process blending or mixing to assure batch
uniformity or to facilitate processing should be
adequately controlled and documented. If the
intent of the operation is to ensure batch uni-
formity, it should be performed so as to assure
homogenous mixing of all materials to the extent
feasible and should be reproducible from batch
to batch (see also Section 8.7.1).

8.5.1.5 In-process control

In-process inspection and testing should be per-
formed based upon monitoring the process or
actual sample analysis at defined locations and
times. Sampling methods should be documented
to ensure that the sample is representative and
clearly labelled.

The results of in-process tests should be record-

ed and conform to established process parame-
ters or acceptable tolerances. Work instructions
should define the procedure to follow and how
to utilise the inspection and test data to control
the process. There should be defined actions to
be taken when the results are outside specified
limits.

Where approval to continue with the process is

issued within the production department, the
specified tests should be performed by trained
personnel and the results should be recorded.

8.5.1.6 Packaging and labelling

Procedures should be employed to protect the
quality and purity of the cosmetic ingredient
when it is packaged, and to assure that the cor-
rect label is applied to all containers. Packaging
and labelling operations should be designed to
prevent mix-ups.

Procedures should be implemented to ensure

that the correct labels are printed, issued and
contain the correct information. The procedure
should also define that any excess labels are
immediately destroyed or returned to controlled
storage. All excess labels bearing batch numbers
should be destroyed. Packaging and labelling
facilities should be inspected immediately before
use to ensure, that all materials that are not
required for the next packaging operation, have
been removed.

26 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
In instances where cosmetic ingredients are
labelled on the packaging line, packaged in
pre-printed bags, or bulk shipped in tank cars,
there should be documentation of the system
used to satisfy the intent of the above principles.

8.5.1.7 Records of equipment use

Records of quality critical equipment use should
be retained. These records should allow the se-
quence of cleaning, maintenance and production
activities to be determined.

8.5.1.8 Validation of processes for

production and service provision
Validation of the manufacturing processes used
for cosmetic ingredients is not necessary as the
product quality can be adequately determined
at the end of processing. Where this determina-
tion is not possible, the manufacturing process
should be validated.

Where cosmetic ingredient manufacturers have

evaluated their processes using process capa-
bility studies, they provide additional assurance
about process control and cosmetic ingredient
quality.

8.5.2 Identification and traceability

8.5.2.1 Traceability
CI-Guidance CI-GMP Standard
Quality critical items, for example raw materials, Identification and traceability are specified re-
packaging materials, intermediates, and finished quirements; the quality management system shall
cosmetic ingredients should be clearly identified include records that allow traceability of the cos-
and traceable through a documented system. The metic ingredient to raw materials and upstream to
quality management system should allow trace- customers.
ability of the cosmetic ingredient to raw materials
and upstream to customers. Identification of raw If defined storage conditions are required to
materials used in batch production processes ensure cosmetic ingredient quality these shall be
should be traceable through the batch numbering stated on the label.
system or any other defined system. Identification
of raw materials used in cosmetic ingredients
manufactured by continuous processing should in-
dicate batches that were present in the equipment
at a designated point in time.

Raw materials, including solvents, are sometimes

stored in bulk tanks or other large containers,
making precise separation of batches difficult.
Nevertheless, the use of such materials should be
documented in production records.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 27
 8.5.2.2 Inspection and test status
There should be a system to identify the in-
spection status of quality critical items includ-
ing raw materials, packaging materials, inter-
mediates, and finished cosmetic ingredients.
Continuously-fed materials may need special
consideration in order to satisfy these require-
ments.

8.5.2.3 Labelling
Labelling requirements for cosmetic
ingredient packages are subject to national
and international regulatory requirements,
which may include transportation and safety
measures. At a minimum, labels should include:
• the name of the cosmetic ingredient, and
grade if applicable;
• the cosmetic ingredient manufacturer’s, and/
or distributor’s name;
• the batch number from which the complete
batch history can be determined;
• if special storage conditions are required,
such restrictions should be placed on the
label or otherwise communicated to the
customer with the consignment.

8.5.3 Property belonging to

customers or external providers
CI-Guidance CI-GMP Standard
Where applicable, the manufacturer should es- No additional requirements to ISO 9001:2015.
tablish and maintain procedures for verification,
storage, and maintenance of customer supplied
materials intended for incorporation into the
customer’s cosmetic ingredient. Verification by the
manufacturer does not relieve the customer of the
responsibility to provide an acceptable material.
Any material that is lost, damaged, or is other-
wise unsuitable for use, should be recorded and
reported to the customer. In this case, procedures
should be in place for acceptable disposition and
replacement of the material. The manufacturer
should also make provisions to protect other real
and intellectual property that is provided by the
customer (e.g., test equipment, test methods, and
specifications).

28 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
8.5.4 Preservation
8.5.4.1 Handling, storage, and
preservation
CI-Guidance CI-GMP Standard
Cosmetic ingredients, intermediates, and raw If defined storage conditions are required to
materials should be handled and stored under ensure cosmetic ingredient quality, these shall be
appropriate temperature, humidity, and light con- stated on the label or otherwise communicated to
ditions, so that their identity, quality, and purity the customer. Records of storage conditions shall
is not affected. Outdoor storage of raw materials be retained for cosmetic ingredients requiring
(e.g., acids, other corrosive substances, or explo- defined storage conditions.
sive materials) is acceptable provided the con-
tainers give suitable protection to their contents,
identifying labels remain legible, and containers
are adequately cleaned prior to opening and use.

If special storage conditions have been identified

as necessary to maintain cosmetic ingredient qual-
ity, then they should be included on the cosmetic
ingredient label. Such cosmetic ingredients should
be stored under these conditions and records of
the conditions should be retained.

8.5.4.2 Packaging systems

CI-Guidance CI-GMP Standard
A cosmetic ingredient packaging system should A cosmetic ingredient packaging system shall
include the following features: include:
• written specifications, examination or testing a) written packaging specifications;
methods; b) a rationale that the packaging does not
• cleaning procedures where containers are introduce impurities to the cosmetic
re-used; ingredient;
• containers that provide adequate protection c) cleaning procedures where containers are
against deterioration or contamination of the re-used.
cosmetic ingredient that may occur during
transportation and recommended storage; The organization shall conduct a risk assessment
• application of tamper evident seals to assure to determine the non-application of tamper evi-
product integrity; dent seals.
• storage and handling procedures which protect
containers and closures and minimise the risk
of contamination, damage or deterioration,
and which will avoid mixups (e.g., between
containers that have different specifications but
are similar in appearance).
• a written justification that the packaging does not
introduce impurities to the cosmetic ingredient.

If returnable cosmetic ingredient containers are

reused, all previous labelling should be removed
or defaced. If the containers are repetitively used
solely for the same cosmetic ingredient, all previ-
ous batch numbers, or the entire label should be
removed or completely obliterated.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 29
 8.5.4.3 Delivery and distribution
CI-Guidance CI-GMP Standard
Identification and traceability of quality critical Distribution records shall be kept that document
items are required of cosmetic ingredient manufac- all cosmetic ingredient shipments.
turers. Distribution records should be kept that doc-
ument all cosmetic ingredient shipments. These re-
cords should identify by cosmetic ingredient batch,
where and to whom the product was shipped, the
amount shipped, and the date of shipment.

The manufacturer should arrange for the protec-

tion of the quality of the product after final inspec-
tion and test. Where contractually specified, this
protection should be extended to include delivery
to the final destination. Cosmetic ingredients
should only be supplied within their expiry and/or
retest period.

8.5.5 Post-delivery activities

CI-Guidance CI-GMP Standard
The intent of this ISO 9001 clause does not usually No additional requirements to ISO 9001:2015.
apply to cosmetic ingredients.

8.5.6 Control of changes

CI-Guidance CI-GMP Standard
Significant changes are those that alter the GMP There shall be a documented procedure defin-
or quality management system status, the quality ing the responsibilities and requirements for the
of the cosmetic ingredient, its performance, regu- evaluation and approval of changes that may
latory status, the services provided, or which may impact the quality of the cosmetic ingredient.
impact or change the known claims made by the The procedure shall define what constitutes a
customer in their use of the cosmetic ingredient. significant change, which as a minimum are those
that alter the quality of the cosmetic ingredient,
Examples of significant changes could be: its performance, regulatory status, or the claims
• the origins of raw materials; made about the cosmetic ingredient. Evaluation
• the cosmetic ingredient formulation, recipe or and approval of changes shall occur prior to the
composition; implementation. The quality unit shall evaluate
• packaging of the ingredient; changes that may impact on the quality of the
• specifications; cosmetic ingredient. Where the impact of the
• test methods; change on the quality of the cosmetic ingredient
• production processes; is determined to be significant, such changes shall
• manufacturing or packaging sites; be communicated to customers. Records of the
• changes to regulatory status etc. change control process shall be retained.

The Quality Unit should be involved in the evalua-

tion of significant changes.

There should be a documented procedure defin-

ing the responsibilities and requirements for the
evaluation and approval of changes (significant
or otherwise) that may impact the quality of the
cosmetic ingredient.

30 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
 Evaluation and approval of changes should occur
prior to their implementation. Records of the
change control process should be retained.

Where the evaluation of the change has deter-

mined that is it significant, then the quality unit
should evaluate these changes and they should be
communicated to customers (see Section 8.2.1).

Note: See also Section 6.3.

8.6 Release of products and services

CI-Guidance CI-GMP Standard
Note: release of purchased products and services Written procedures shall be established to mon-
is covered in Section 8.4.2. itor and control the quality characteristics of
cosmetic ingredients.
The cosmetic ingredient manufacturer should es- These shall include, as applicable:
tablish the test methods and procedures to ensure a) laboratory controls;
the product consistently meets specifications. b) cosmetic ingredient testing and release;
c) out-of-specification test results;
Analytical methods should be fit for purpose and d) retained samples;
should provide a high degree of assurance about e) certificate of analysis;
their suitability. f) impurities;
g) stability;
h) expiry/retest periods.

Records of in-process and final cosmetic ingredi-

ent testing shall be retained and shall identify the
person performing the tests and the dates the
tests were performed.

The Quality Unit shall be responsible for the con-

tent and approval of Certificates of Analysis.

The organization shall evaluate cosmetic ingre-

dient stability based on historic data or specific
studies. The organization shall define and justify
an expiry or retest interval and ensure this is com-
municated to the customer.

Samples shall be kept for a defined period. The

period shall be justified.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 31
 8.6.1 Laboratory controls
Laboratory controls should include data
derived from all tests necessary to ensure
conformance with established specifications
and standards, for example:
• a description of the sample received for
testing including the material name, batch
number or other distinctive code, and date
the sample was taken;
• a statement referencing each test method
used;
• a record of raw data secured during each
test including graphs, chromatograms,
charts, and spectra from laboratory
instrumentation, identified to show the
specific material and batch tested;
• a record of calculations performed in
connection with the test;
• test results and how they compare with
established specifications;
• traceability to the person who performs
each test and the date(s) the tests were
performed.

There should be a written procedure for

the preparation of laboratory reagents
and solutions. Purchased reagents and
solutions should be labelled with the name,
concentration, and expiry date. Volumetric
solutions should be standardized according
to an internal method or using a recognised
standard.

8.6.2 Cosmetic ingredient testing and

release
Cosmetic ingredient testing should be per-
formed on each batch or lot to ensure that
the cosmetic ingredient conforms to written
specifications. For cosmetic ingredients pro-
duced by continuous processes assurance that
the cosmetic ingredient conforms to document-
ed specification may be achieved through the
results of in-process testing or other process
control records.

Cosmetic ingredient batch release should be

based on conformance to final test specifica-
tions and an evaluation of the manufacturing
process records.

32 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
8.6.3 Out-of-Specification test results
Out-of-specification (OOS) test results should
be investigated and documented according to a
documented procedure.

Retest sample results may only be used to re-

place the original test result if it is demonstrated
that the original result is erroneous, based on a
documented investigation.

When statistical analysis is used, both the

original and retest data must be included. The
OOS procedure should explain which statisti-
cal techniques are to be used and under what
circumstances.

These same principles apply when the sample

is suspected of not being representative of the
material from which it was taken.

8.6.4 Retained samples

Where it is practical, retained samples of the
cosmetic ingredient should be kept. The reten-
tion period should be defined. The period should
be justified based on the nature of the cosmetic
ingredient and the knowledge of its stability. The
retained samples should be stored and main-
tained in such a manner that they are readily
retrievable in facilities that provide a suitable
environment. The sample size should be at least
twice the amount required to perform complete
specification testing.

8.6.5 Certificates of Analysis

Where the customer requires it, certificates of anal-
ysis should be provided to the required specifica-
tion for each batch of cosmetic ingredient supplied.
The Quality Unit is responsible for the content and
approval of Certificates of Analysis.

8.6.6 Impurities
Manufacturers should be aware of the impuri-
ties and their typical levels present in cosmetic
ingredients.

Any impurity critical to product quality should

be identified and have appropriate limits es-
tablished. Manufacturing processes should be
adequately controlled so that the impurities,
including solvent residues, do not exceed such
established specifications.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 33
 8.6.7 Stability
There should be data to support the assigned
stability of the cosmetic ingredient. Many cos-
metic ingredients are stable and may not require
testing to demonstrate their stability. For cosmet-
ic ingredients that have been in the market for a
long time, historic and/or retrospective data of
the material and its uses may be used to demon-
strate stability.

Where there is no information about stability, a

documented testing and/or evaluation program
designed to assess the stability characteristics of
the cosmetic ingredient should be undertaken.

8.6.8 Expiry/Retest periods

An expiry or retest period for each cosmetic in-
gredient should be assigned and justified. Where
stability data is available, it can be used to assign
the expiry or retest period. Common practice
is to use a retest period, rather than an expiry
period. The expiry or retest period should be
communicated to the customer.

8.7 Control of non-conforming outputs

CI-Guidance CI-GMP Standard
Raw material, intermediate, or finished cosmet- The organization shall deal with nonconforming
ic ingredient found not to meet its specification product by one or more of the following ways
should be clearly identified and controlled to pre- e) by blending, reprocessing or reworking.
vent inadvertent use or release for sale. A record Where this is not a normal part of the
of non-conforming product should be maintained. manufacturing process it shall be documented
Incidences of non-conformance should be investi- in a batch record to ensure traceability, and
gated to identify the root cause. The investigation f) by defining procedures for the holding,
should be documented and corrective action taken testing, and reprocessing of the returned
to prevent recurrence of the problem. cosmetic ingredient. Records of returned
products shall be maintained.
There should be a procedure defining how the
recall (withdrawal) of a cosmetic ingredient should There shall be a procedure defining how to trace
be conducted. The procedure should describe a batch of a material and manage a recall (with-
how traceability upstream and downstream can drawal) of a cosmetic ingredient. The ability to
be achieved starting with a specific material perform traceability of a material shall be tested
which may include a raw material or a cosmetic at least annually.
ingredient. The ability to trace a batch of material,
such that a recall could be affected, should be
tested at least annually.

Procedures should exist for the evaluation and

subsequent fate of non-conforming products.
Nonconforming product should be reviewed in
accordance with documented procedures to

34 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
 determine its final outcome. The non-conforming
product may be:
• reprocessed/reworked to meet the specified
requirements;
• accepted with the agreement of the customer;
• re-graded for other applications;
• destroyed.

8.7.1 Reprocessing/Reworking
Blending, reprocessing or reworking that is not a
normal part of the manufacturing process should
be documented in the original batch record or a
new one to ensure traceability.

When considering reprocessing or reworking,

a review of risk to cosmetic ingredient quality
should be undertaken, and consideration should
be given to:
• new impurities that may have been
introduced as a result of the reprocessing/
reworking;
• additional testing to control the reprocessing/
reworking;
• establishment of suitable acceptance criteria
for the reprocessed/reworked cosmetic ingre-
dient;
• performance.

The equivalence of the quality of reprocessed/re-

worked material to original material should also
be evaluated and documented to ensure that
the reprocessed/reworked batch will conform
to established standards, specifications, and
characteristics.

9 Performance evaluation

9.1 Monitoring, measurement, analysis

and evaluation
9.1.1 General
CI-Guidance CI-GMP Standard
The organization should plan and implement the No additional requirements to ISO 9001:2015.
monitoring, measurement and improvement
activities required to demonstrate conformity of
the product and to ensure conformity of the quality
management system.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 35
 The organization should evaluate opportunities
for improvements through the measurement and
analysis of product and process trends.

The cosmetic ingredient manufacturer should

identify the tests and measurements necessary
to adequately control manufacturing and quality
management system processes. Where appropri-
ate, techniques that may be used to verify that the
processes are under control should be established.

When deviations from planned results occur,

corrective action should be taken to ensure the
product meets requirements.

Periodic reviews of key indicators such as process

quality attributes and process failures should be
conducted to assess the need for improvements.

9.1.2 Customer satisfaction

CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should es- No additional requirements to ISO 9001:2015.
tablish measurement activities to assess customer
satisfaction. Such measurements can include for
example, customer complaints, return of cosmetic
ingredients, and customer ratings of the cosmetic
ingredient manufacturer. This information should
drive activities that strive to continuously improve
customer satisfaction.

9.1.3 Analysis and evaluation

CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should No additional requirements to ISO 9001:2015.
develop methods for evaluating the effectiveness
of its quality management system to identify
opportunities for improvement. Such data can
be derived from customer complaints, product
reviews, process capability studies, internal audits,
and audits by the customer. The analysis of such
data may be used as part of the management
review (see Section 9.3).

It is suggested that a periodic review of key indica-

tors such as product quality attributes, customer
complaints and product non-conformities, should
be conducted to assess the need for improve-
ments.

36 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
9.2 Internal audit
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should The internal audit programme shall include infor-
carry out a comprehensive system of planned and mation on whether the quality management sys-
documented internal quality audits to determine tem conforms to the requirements of EFfCI GMP.
whether quality activities comply with planned ar-
rangements including conformance to EFfCI GMP
and to determine the effectiveness of the quality
management system. Audits should be sched-
uled on the basis of the status and importance of
the activity. Audits and followup actions should
be carried out in accordance with documented
procedures.

Audit results should be documented and discussed

with management personnel having responsibility
in the area audited. Management personnel re-
sponsible for the area audited should take correc-
tive action on the non-conformities found.

9.3 Management review

9.3.1 General
CI-Guidance CI-GMP Standard
The top management of the company should hold The review of the performance of the quality man-
periodic reviews of the quality management sys- agement system shall include EFfCI GMP.
tem and GMP application to confirm the organiza-
tion’s continued conformance to this guide.

The review should be recorded and include assess-

ing opportunities for improvement and the need
for changes to the quality management system.

9.3.2 Management review input

CI-Guidance CI-GMP Standard
Management review inputs should include for The management review shall be planned and
example: carried out taking into consideration:
• results of internal and external audits; c) information on the performance and
• customer ratings of the company performance; effectiveness of the quality management
• product conformity and process performance; system including trends in:
• action items from the previous management 8) conformance to the requirements of EFfCI
review; GMP
• customer complaints;
• status of preventive or corrective actions;
• changes that could affect the quality
management system;
• the operation of the quality management
system in terms of the implementation of
cosmetic ingredient GMP requirements.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 37
 9.3.3 Management review outputs
CI-Guidance CI-GMP Standard
The management review should identify the No additional requirements to ISO 9001:2015.
resources needed and opportunities presented for
improvement of the quality management system
and improvement of product conformance to
customer and regulatory requirements. A record
should be made of all actions ordered and taken.

10 Improvement

10.1 General
CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should take No additional requirements to ISO 9001:2015.
proactive measures to continuously improve manu-
facturing and Quality Management System process-
es. The cosmetic ingredient manufacturer should
establish, document, and maintain procedures for:
• investigating the cause of non-conforming
product, findings from internal audits, customer
returns, and complaints along with the
corrective action needed to prevent recurrence;
• analysing processes, work operations,
concessions/special release, quality records,
and to detect and eliminate potential causes of
non-conforming product.

10.2 Nonconformity and corrective action

CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should No additional requirements to ISO 9001:2015.
establish, document, and maintain procedures for:
• applying controls to ensure that corrective
actions are taken and that they are effective;
• implementing and recording changes in
procedures resulting from corrective action;
• determining the causes of non-conformities.

10.3 Continual improvement

CI-Guidance CI-GMP Standard
The cosmetic ingredient manufacturer should No additional requirements to ISO 9001:2015.
establish, document, and maintain procedures for:
• initiating preventive actions to deal with problems
at a level corresponding to the risks encountered;
• implementing and recording changes in
procedures resulting from preventive action.

38 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
APPENDIX A Definitions and Glossary

As used throughout this guide, the terms below have Contaminant

the following meaning. An impurity not intended to be present in a material
that may be introduced through such things as poor
Batch (Lot) cleaning, processing, or the lack of appropriate envi-
A specific quantity of material produced in a process ronmental and personnel controls during the manufac-
or series of processes so that it can be expected to be turing process.
homogeneous. In the case of continuous processes,
a batch may correspond to a defined fraction of the Continuous Process
production. The batch size can be defined either by A manufacturing process that continually produces
a fixed quantity or by the amount produced in a fixed material from a continuing supply of raw material.
time interval.
Cosmetic Ingredient (CI)
Batch Number (Lot Number) Substances or preparations that are intentionally in-
A distinctive identification (e.g. combination of num- cluded in a cosmetic product.
bers letters and/or symbols) that identifies a batch
and from which the production and distribution histo- Cosmetic Product
ry can be determined. “Cosmetic product” means any substance or mixture
intended to be placed in contact with the external
Batch Process parts of the human body (epidermis, hair system, nails,
A manufacturing process that produces the cosmetic lips and external genital organs) or with the teeth and
ingredient from a discrete supply of raw materials that the mucous membranes of the oral cavity with a view
are present before the completion of the reaction. exclusively or mainly to cleaning them, perfuming
them, changing their appearance, protecting them,
Batch Record keeping them in good condition or correcting body
Documentation that provides the history of a batch odours. (Regulation (EC) No 1223/2009 of the Europe-
from the raw materials used, manufacturing steps an Parliament and of the Council of 30 November 2009
performed and in-process and final testing. on cosmetic products, Article 2, 1(a).)

Blending (Mixing) Critical Deficiency

Blending is the process of combining materials to pro- A deficiency which has produced, or leads to a signif-
duce a homogeneous substance. icant risk of producing a product which is harmful to
the customer or which does not comply with regulato-
Calibration ry requirements or commercial claims.
The demonstration that a particular instrument or
device produces results within specified limits by Critical Process
comparison with those produced by a reference or A manufacturing process step that directly influences
traceable standard over an appropriate range of mea- quality attributes.
surements.
Cross-Contamination
Certificate of Analysis (CofA or CoA) Contamination of a raw material, intermediate, or a
A document listing the results of testing a representa- finished cosmetic ingredient with another raw materi-
tive sample drawn from the batch to be delivered. al, intermediate, or cosmetic ingredient during produc-
tion.
Concession
An agreement reached with a customer whereby they
accept a non-conforming material.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 39
Customer Mother Liquor
The next organization to receive the cosmetic ingredi- A concentrated solution from which the product is ob-
ent once it has left the control of the cosmetic ingredi- tained by evaporation, freezing, and/or crystallization.
ent manufacturer, brokers, agents and distributors.
Nonconforming Material
Expiry (Expiration) Date Any material that does not meet the manufacturer’s
The date beyond which, a product may no longer con- specifications or that has not been manufactured ac-
form to relevant specifications. cording to applicable GMP.

Good Manufacturing Practices (GMP) Packaging

That part of quality assurance which ensures that The act of filling a cosmetic ingredient into a container.
products are consistently produced and controlled
with a quality standard appropriate to their intended Packaging Material
use. The containers, closures, and labels employed in the
packaging of a product.
Homogeneous (Material)
Material of uniform consistency and composition Production
throughout a batch. See manufacturing process.

Impurity Quality
Any component of a cosmetic ingredient that is not the The totality of features and characteristics of a prod-
desired entity. uct that bear on its ability to satisfy stated or implied
needs.
In-process Testing Quality Assurance
Monitoring checks performed during production to All the planned and systematic actions necessary to
ensure that the process is in control and the material, provide confidence that a product or a service will
substance, or product conforms to established specifi- satisfy given requirements for quality.
cations.
Quality Control
Intermediate (Product) Includes all activities such as measuring, examining,
Material that must undergo further manufacturing testing, or gauging one or more characteristics of a ma-
steps before it becomes a finished cosmetic ingredient. terial (including finished cosmetic ingredients, inter-
mediates, packaging materials and starting materials)
Lot and comparing the findings with specified require-
See “Batch”. ments to determine conformity.

Manufacturer Quality Unit (ref: ICH Q7)

A company holding the trademark for the cosmetic An organizational unit independent of production
ingredient or that performs the final release of the which fulfils both Quality Assurance and Quality Con-
cosmetic ingredient. trol responsibilities. This may be in the form of sepa-
rate QA and QC Units, a single individual (or group),
Manufacturing Process depending on the size and structure of the organiza-
All the steps necessary to produce a finished cosmetic tion.
ingredient.
Raw Material
Master Production Instruction See “Starting Material”.
Documentation that describes the manufacture of the
cosmetic ingredient from raw material to completion
of the batch.

40 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
Recall Specification
A process for withdrawing or removing a cosmetic in- A list of tests, references to analytical procedures, and
gredient from the distribution chain because of defects appropriate acceptance criteria for a material.
in the material or complaints of a serious nature. Does
not necessarily involve notification of any regulatory Stability
authority. Continued conformance of the cosmetic ingredient to
its specifications.
Representative Sample
A sample drawn according to an appropriate sampling Starting Material
plan, which may involve regular or random selection. Any substance used in the production of a cosmetic
ingredient excluding packaging materials.
Reprocessing
Introduction of previously processed material which Top Management
did not conform to standards or specifications back Person or group of people who direct and control an
into the process and repeating one or more neces- organization at the highest level. The highest level can
sary steps that are part of the normal manufacturing either be at the site or on corporate level and will de-
process. pend on the way that the quality management system
is organized.
Retained Sample
A representative sample from the finished cosmetic in- Traceability
gredient batch that is of sufficient quantity to perform Ability to track the history, application or location of
at least two full quality control analyses. that which is under consideration.

Retest Date Verification

The date beyond which the cosmetic ingredient should Confirmation by examination of objective evidence
not be used without further appropriate re-examina- that the specified requirements have been fulfilled.
tion.
Validation
Returned Products A program that provides a high degree of assurance
Finished cosmetic ingredients returned to the manu- that a specific process, method, or system will consis-
facturer for a specified reason. tently produce a result meeting predetermined accep-
tance criteria.
Reworking
Introducing previously processed material that did not Withdrawal
conform to standards or specifications to processing See Recall.
steps that differ from the normal process.

Sanitization (ref ISO 22716)

An operation, used to reduce undesirable micro-organ-
isms on inert contaminated surfaces depending on the
objectives set.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 41
APPENDIX B References

International Organization for Standardization, Quality Management Systems-Requirements, ISO

9001:2015.

IPEC PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (2006).

Regulation (EC) No 1223/2009 of the European parliament and of the council of 30 November 2009 on
cosmetic products (recast).

42 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
APPENDIX C Additional Sources of Information

The following references provide further information about the various GMP guides and standards
that are used in other industries. The concepts and controls may provide useful sources of additional
information.

Active Pharmaceutical Ingredient (API) Process Inspection Chapter 56, Drug Quality Assurance, Program
7356.002F, FDA Compliance Program Guidance Manual, September 11, 2015.

Code of Federal Regulations Title 21 Food and Drugs Parts 210 and 211, US Food and Drug Administration
(FDA), Washington DC, USA.

Codex Alimentarius – General Principles of Food Hygiene CAC/RCP 1-1969 (Adopted 1969. Amendment
1999. Revisions 1997 and 2003. Editorial corrections 2011) Food and Agriculture Organization of the
United Nations and World Health Organization, Rome, 2003.

ISO 22000:2005 Food safety management systems -- Requirements for any organization in the food chain

European Commission, Committee for Proprietary Medicinal Products, The Rules Governing Medicinal
Products in the European Union, Volume 4, Good Manufacturing Practices.

European Union, Commission Directive, 2004/27/EC, amending Directive 2001/83/EC on the community
code relating to medical products for human use and later updates.

European Union, The Rules Governing Medicinal Products in the European Union, Notice to Applicants,
Volume 2B CTD.

European Union, Council Directive, (EC) 852/2004, On the Hygiene of Foodstuffs.

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

Hazard Analysis and Critical Control Point Principles and Application Guidelines, FDA - August 1997.

International Conference on Harmonization (ICH), Note for Guidance on Good Manufacturing Practices for
Active Pharmaceutical Ingredients Q7A, 2001.

International Standard ISO 19011:2011, Guidelines for auditing management systems

International Standard ISO 9000:2015, “Quality Management Systems - Fundamentals and Vocabulary”.

IPEC Good Manufacturing Practices Audit Guideline for Bulk Pharmaceutical Excipients, 2008.

IPEC Certificate of Analysis Guide for Bulk Pharmaceutical Excipients, 2013.

IPEC-Federation Significant Change Guide for Bulk Pharmaceutical Excipients, 2014.

Pharmaceutical Inspection Convention, PE 009-13 (Part II) 1 January 2017, Guide for Good Manufacturing
practice for Medicinal Products Part II.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 43
APPENDIX D EFfCI GMP Certification Scheme Rules

Requirements for delivering EFfCI GMP Guide certified supplier status

1 European Federation for Cosmetic Ingredients (EFfCI)

EFfCI shall:
a) administer the EFfCI GMP Certifiable Standard and set up agreements with interested parties,
b) develop and publish the EFfCI GMP Guide and Certifiable Standard,
c) issue EFfCI rules of use to certification bodies and certified companies,
d) publish a list of approved certification bodies
f) publish a list of certified companies, and the validity dates of the certificates,
g) establish GMP Committee to oversee the scheme and which will address any issues arising from
the implementation of the scheme,
h) update and amend the Scheme and the GMP Guide in light of experience in the operation of this
scheme, and
i) where an accreditation body or organization has an issue with the Scheme, convene an expert
panel that are comprised of members of the EFfCI GMP Committee to review the situation and
make appropriate recommendations to resolve the issue. No member of the expert panel shall
have any interest in the issue.
j) Design, update and deliver a training course for auditors who will assess cosmetic ingredient sup-
pliers against the GMP requirements in Annex E.
k) EFfCI will provide approved LOGOS for use by Certifying Bodies and their clients.

2 The accredited certification body

The accredited certification body shall:
a) be accredited to ISO 17021 series of standards by the independent organization in the country
that the certification body is registered, and apply the requirements in ISO 17021 to EFfCI audits,
b) sign an agreement with EFfCI to meet the EFfCI GMP Certifiable Standard requirements including,
i) all certification audits (including surveillance/periodic and re-certification audits) shall be
carried out by qualified auditors/lead auditors meeting the requirements in section 3 of this
appendix,
ii) all the EFfCI GMP Certifiable Standard requirements shall be assessed at every certification
and recertification audit, and
iii) surveillance/periodic audits shall be carried out at least annually. These audits shall cover at
least half of the quality system such that all the EFfCI GMP requirements will be reviewed by
the two surveillance audits that occur in between recertification audits.
c) ensure that the cosmetic ingredient supplier holds and continues to hold a valid and accredited
ISO 9001 certificate. Verification of this requirement can be met by reviewing the last ISO 9001
audit report, validation of the current ISO 9001 certificate, etc.
d) ensure EFfCI GMP Certifiable Standard supplier auditors are experienced and familiar with the
technology of the cosmetic ingredient supplier company/client concerned, and have either at-
tended an EFfCI Auditor training course or attended the training course “in house” delivered by a
trainer who has attended an EFfCI Auditor training course.
e) provide feedback on the EFfCI GMP Certifiable Standard’s effectiveness,
f) following the outcome of the audit, promptly inform EFfCI about the status of the EFfCI GMP Cer-
tificate, and immediately advise EFfCI if certification is suspended or withdrawn,
g) permit their logo to be included on the EFfCI GMP Scheme certificate,
h sign issued certificates
i) seek clarification/advice from EFfCI as necessary

44 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
 j) comply with the audit duration requirements and guidelines below
k) comply with the multi-site audit requirements and guidelines below.
l) pass on the use of the EFfCI GMP Certified organization logo rules to cosmetic ingredient supplier:
• There should be no implication that the product is certified, but only that the management
system used to make the product is certified.
• The Certifying Body should apply the same rules concerning the use of their management sys-
tem logo as the EFfCI one (i.e. to ensure correct communication of the scope and application
of GMP by the certified organization)

3 The auditor
The auditor shall:
a) meet the EFfCI GMP Certifiable Standard Auditor requirements. They should meet the accredited
certification body’s requirements to be a lead auditor / auditor. Auditor registration with IRCA,
ICQ-CEPAS or equivalent schemes, is desirable,
b) have experience/familiarity with the manufacturing technology used by the chemical industry,
cosmetic industry, or the pharmaceutical industry, and
c) have attended an EFfCI Auditor Training Course run publically or “in house” by a trainer who has
attended the EFfCI Auditor Training Course.

4 The organization
The organization (cosmetic ingredient supplier company) shall:
a) hold a current and valid accredited ISO 9001 certificate. Self-certification is not acceptable,
b) include the EFfCI GMP Certifiable Standard requirements in its quality system,
c) seek certification to the EFfCI GMP Certifiable Standard from an EFfCI approved certification body
(see Section 1.1 d),
d) if appropriate, make suggestions for improving the EFfCI GMP Guide and Certifiable Standard to
EFfCI or the Certifying body,
e) seek clarification/advice from EFfCI as necessary.

Audit duration requirements and guidance

Audit durations shall be determined based on the scope and activities conducted by the cosmetic ingredi-
ent supplier and in accordance with ISO 17021 recommendations. As a minimum audit durations for an
EFfCI GMP stand-alone audit shall be:

Initial Certification: 2 days

Surveillance Audit 1 day
Recertification Audit 2 days

Note: These durations are in addition to any ISO 9001:2015 audit durations.

1. For scope extension during a surveillance visit, the minimum additional duration should be
recalculated after considering the complexity of the added activity.

2. Deviations in audit durations: the durations above identify a starting point for audit durations,
which should be adjusted for any special attributes of the organization and or system to be audit-
ed.

EFfCI GMP audit durations may be reduced by a maximum of 50% if the EFfCI GMP Audit is com-
bined with and ISO 9001:2015 audit or if an EFfCI GMP audit is combined with an EXCiPACT™
GMP Audit.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 45
 The following factors should be considered to increase the allocated audit time (non-exhaustive):
• Complexity of logistics (e.g. involving more than one location)
• Staff speaking more than one language, where translators are required or auditors are unable
to audit independently
• Complexity and quantity of manufacturing processes, technologies.
• Quantity of product groups/families of different types.
• Size and dispersion of the site.
• Older sites, difficult material flow
• Time consuming access procedures to high risk areas
• Number of non-conformances recorded in any previous evaluation
• Difficulties experienced during the evaluation requiring further investigation (cannot be tak-
en into account at proposal stage)
• Any outsourcing within the scope of certification

The above points for deviations in the audit duration are indicative and do not cover all situations and
all attributes of the specific organization’s system, processes and products or services that should be
considered when determining audit time.

In cases where audit durations are less than these minimum requirements, approval shall be sought
from EFfCI.

Multiple site organizations and audit durations

The EFfCI Certification Scheme is based on ISO 9001 certification and so permits a reduced number of
audits in certain circumstances. Multiple site organizations may be considered in EFfCI certification pro-
vided that they meet the definition and basic requirements listed in the International Accreditation Forum
(IAF) MD1:2007 (§1.5, 2 and 3). These circumstances are indicated herein.

The International Accreditation Forum (IAF) allows for a reduced number of physical audits (“sampling”)
when manufacturing sites operate the same quality management system and processes. In regard to de-
termining if a reduced number of audits may be applied then IAF states (IAF MD 1:2007):
• not all of those organizations are eligible for a sampling.
• “the sampling should not be applied where site sampling is inappropriate to gain sufficient confi-
dence in the effectiveness of the management system under audit”.  The scope, complexity of the
operations and the risks associated to the type of activities are some of those reasons.

The following requirements on EFfCI-GMP certifications shall be applied by all multiple sites organiza-
tions meeting the pre-requisites listed in IAF-MD1:2007:
• The central office (as defined in 1.5 and 2.3.1 of IAF MD1 in annex) shall be visited each year and
the specific responsibilities identified in IAF MD1:2007 §3 will be confirmed.
• The initial certification audit will cover each single site. A first multiple-site certificate will be
delivered listing all sites having passed successfully this audit.
• After the initial certification, when a new site is willing to be added on the multiple-site certificate,
it will go under a full audit with a positive recommendation for certification.
• The initial certification will be composed of a stage 1 and a stage 2, with a stage 1 at least at the
central office but also in any other site where this has been found as relevant (e.g. a site where
specific management functions have been delegated by the central office).
• The audit duration at any new site willing to join an existing certificate shall be considered as for
an initial audit.
• Each site shall be visited at least once per 3 years. 

46 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
 • The audit program of the cycle (including eventual reduction of the audit frequency) shall be de-
fined by the certification body in such a manner that:
○ a uniform distribution of the quantity of sites during the cycle is ensured,
○ the outcome of the previous audit as well as other relevant parameters such as quantity of
different product types, presence of critical processes and/or activities, etc…are taken into
account.
• Should a major non-conformity be identified on a site during an initial certification audit, or
during a surveillance or renewal audit where a reduced audit frequency applies, this site shall be
re-visited the year after.
• The certificate shall be suspended/withdrawn in its entirety if the central office or any one of the
sites does not fulfil the necessary provisions for the maintenance of the certification.

Approved Logo for use by Certifying Bodies and their clients

This version is for illustration. A high quality image file is available on request from EFfCI at
[email protected].

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 47
APPENDIX E EFfCI GMP Certification Standard –
Auditor Competency and Training Requirements

EFfCI Auditor Competency Requirements

The following requirements should be met by EFfCI GMP Auditors:

Education:
The candidate shall have a tertiary education in a scientific discipline (chemistry, biology, microbiology,
pharmaceutical or cosmetic science).
Where a tertiary education has not been attained then a substantial (more than 10 years) experience in
relevant fields can be considered.

Work experience:
The candidate should have demonstrated experience:
• a minimum of 2 years work experience in the quality unit at pharmaceutical/cosmetic/chemical/
food manufacturing company with responsibilities that include conformance to GMP in a quality
assurance position, or
• at least 5 years audit experience in numerous pharmaceutical/cosmetic/chemical/food manufac-
turing operations to a recognized GMP standard (i.e. ISO/FSSC22000, ISO22716, ICHQ7, etc.)

Audit experience:
The candidate shall demonstrate sufficient skills in auditing practices.
Therefore, the candidate shall:
• be trained against ISO9001;
• meet the requirements for Lead Auditor qualification for ISO9001 or other quality related man-
agement systems based on the standard ISO high level hierarchy, or be an EXCiPACT registered
auditor;
• demonstrate the execution of at least 5 audits in the previous two years against ISO9001 require-
ments or equivalent that includes conformity to GMP (i.e. ISO/FSSC22000, ISO22716, ICHQ7,
EXCiPACT…).

Knowledge:
The candidate shall demonstrate knowledge and understanding of the EFfCI-GMP requirements, cosmetic
industry, quality and legal requirements and quality risk management by:
• attending an EFfCI training course (see below), and
• any other documented evidences of relevant qualification, education, training, work and/or audit
experience related to those topics.

EFfCI Auditor training course

An auditor training course has been developed by EFfCI in accordance with this appendix.

Attendance at the course is mandatory for Certifying Bodies trainers who will deliver it “in house” to the
Certifying Bodies auditors. Certifying Body trainers shall also meet the requirements for an EFfCI GMP
Auditor.

EFfCI Certification Auditors must attend either the “in house” course or the EFfCI one.

The following sections will also be useful as an aid to those who will be audited against the requirements
of the scheme.

48 • E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7
These training requirements are aimed at ensuring auditors can reliably and consistently assess cosmetic
ingredient suppliers for compliance with the EFfCI GMP Certification standard.

These training requirements have been designed to illustrate the key principles of GMP, in particular to
auditors who are familiar with the chemical industry. Similarly these requirements will help auditors who
are familiar with more demanding GMP industries (e.g. pharmaceuticals) relate to the less documented
systems that will be in place for the manufacture of cosmetic ingredients.
The EFfCI training course covers all of these key aspects.

Prerequisites
➣ What is a cosmetic?
• Any substance or preparations to be placed in contact with the various external parts of
the human body (epidermis, hair system, nails, lips and external genital organs) or with
the teeth and mucus membranes of the oral cavity with a view exclusively or mainly to
cleaning them, perfuming them, changing their appearance and or correcting body odours
and or protecting them or keeping them in good condition (1223/2009/EC).

➣ What is a cosmetic ingredient?

• Any substance or preparation that is intentionally included in a cosmetic product.
Note that some substances are prohibited in law (Annex II of the cosmetic directive
1223/2009/EC) but there is no corresponding positive list of substances. The key re-
quirement for a substance is that it has been assessed for safety in the cosmetic, but this
duty lies with the cosmetic manufacturer.
• Substances and materials that:
• Impart a specific cosmetic effect. Usually these materials can be the basis of a label
claim by the cosmetic manufacturer,
• Functional aid to a formulation, e.g.
○ Surfactants,
○ Rheology modifiers,
○ Appearance modifiers,
○ Preservatives and antioxidants,
○ Colourants,
○ Perfumes,
○ Etc.
• These substances can be manufactured by chemical, biological synthetic and other suit-
able methods.

➣ What is GMP?
• That part of quality assurance which ensures that products are consistently produced and
controlled with a quality standard appropriate to their intended use. The GMP principles
are elaborated in a later section.

➣ What is Cosmetic Ingredient GMP?

• The application of the principles of GMP to the manufacture of cosmetic ingredients, such
that the safety of the cosmetic ingredient is assured in a reproducible manner.
• A set of rules designed to minimise or eliminate the risks posed to end users (consumers)
from poor quality and or contaminated cosmetic ingredients.
• An emphasis on the application and implementation of the GMP principles (see next sec-
tion) which are sufficiently documented.
• Note: Validation of the manufacturing processes (including cleaning methods, equipment,
computer and analytical methods) is not normally undertaken where the product quality
can be adequately determined at the end of processing.

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 GMP Principles
The following principles should be applied in relation to the risks posed to the user of the cosmetic, i.e. the
consumer.

➣ The product shall not intentionally or unintentionally harm the end user,
➣ The product specification is not a complete definition of product quality,
➣ Product purity,
• Contamination control,
• Microbiology,
• Dust and dirt,
• Foreign objects,
• Water quality,
• Sampling activities,
• Etc.
• Cross contamination control from other substances in the manufacturing environment,
including other products, raw materials and process aids (e.g. lubricants etc.),
• Personal Hygiene,
• Equipment and workplace cleanliness,
• Equipment maintenance,
➣ Consistency of product quality from batch to batch,
Through use of the same,
• Product plant/manufacturing process,
• Raw materials,
• Analysis of batches,
• Recipe,
• Controls over reprocessing and reworking,
• Controls over reused ingredients (e.g. solvents, recrystallisations),
➣ Change Management System,
• Consideration of impact of change on product quality before implementation of the
change,
• Verification that changes result in a product that is unaltered and has the same perfor-
mance,
➣ Traceability of actions to planned arrangements,
• Records of these activities (equipment use, personnel performing functions, labelling
etc.),
➣ Traceability of raw materials to finished products
• Not optional,
➣ Traceability of sold products to customers,
• Not optional,
• Ability to recall a batch from the market,
➣ Scientific basis for making product quality decisions – Good science - a result is worth a thousand
words,
• Use of risk assessments (to product quality and end user safety),
➣ Suitable evidence of cosmetic ingredient stability in the supply chain up until the point of use by
the cosmetic manufacturer,
➣ Out of Specification Procedure,
• Scientific evaluation of unexpected results,
➣ Quality unit separate from production and commercial pressures,
• Product release,
➣ Calibration of critical manufacturing and analytical equipment,
• Note this is to the same standards as required in ISO 9001.

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Main differences between standard and ISO 9001
➣ Emphasis to controlling the quality of the cosmetic ingredient,
➣ Commitment to GMP policy, QA Manual, communication to customers etc.,
➣ Enhanced role of quality unit in regard to,
• Reviewing and approving quality documents,
• Batch release,
➣ Requirement to define specific responsibilities, e.g.
• Supplier approval,
• Raw material, packaging release for use,
• Batch release,
• Etc.
➣ Additional requirements for documented procedures (as applicable),
• Laboratory controls;
• Cosmetic ingredient testing and release,
• Out-of-specification test results,
• Retained samples,
• Certificate of Analysis,
• Impurities,
• Stability,
• Expiry/Retest periods,
• Reworking,
• Product Recall,
➣ Additional requirements for records of activities,
• Clarity of records,
• Traceability to person performing activity,
• Record retention periods,
• Returned goods,
➣ Emphasis on control of the work environment to prevent contamination, for example and as
applicable through controls over personnel hygiene practices, equipment construction and
maintenance, cleaning etc.
➣ Traceability is not optional,
➣ Raw material and packing specifications.

Key risks for auditors to identify

➣ Threats to product quality and purity,
• Management commitment to GMP,
• Implementation of GMP principles throughout the Quality Management System,
• Competency of personnel performing critical functions (e.g. handling exposed product,
authorising changes, batch release etc.) with respect to the principles of GMP,
• Visual appearance of the work environment especially where the product is exposed to
that environment,
• Calibration of critical process equipment,
• Implementation if suitable cleaning of manufacturing equipment,
• Suitable and sufficient documented procedures to support these critical activities,
including who authorises changes,
• Records of material and equipment use so that traceability can be effected,
• Rework processes that have not been evaluated for impact on product quality
• Product release process.

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APPENDIX F Clauses in Section 8
Which Are Not Applicable to Distributors

A simple distributor of cosmetic ingredients which have been packaged and labelled by the manufacturer
and in which storage and transportation activities are performed may not be required to comply with all
clauses in Section 8, Operations. All other clauses in the GMP Standard shall apply to such organizations.

This Appendix indicates which clauses are not expected to apply to such organizations. However should
the organization, relable, repack or their activities pose a threat to the quality and purity of the cosmetic
ingredient then all clauses in Section 8 shall be assessed at any Certification Audit.

Exempted Clauses:
8.1 Operational planning and control
Sampling plans and testing may not be assessed if the organization is not responsible for the
status of the cosmetic ingredient and issues the cosmetic ingredient Certificate of Analysis as
received from the manufacturer.

8.5 Production and service provision

Those clauses in this section that relate to production activities may not be assessed. Sufficient
controls shall be applied to assure the service provision applied to the storage and transport of
cosmetic ingredients.

8.5.2 Identification and traceability

This remains a requirement but it shall not be necessary for the organization to demonstrate
traceability to the cosmetic ingredient raw materials: traceability to the manufacturer is
sufficient.

8.5.4 Preservation
The organization shall comply with any specific storage conditions necessary to assure
the cosmetic ingredient quality as stipulated by the cosmetic ingredient manufacturer. The
organization shall ensure that such conditions are communicated to their customers.

The organization shall not be required to define the cosmetic ingredient packaging system.

8.6 Release of products and services

Those activities in this section that relate to testing activities shall not apply to the cosmetic
ingredient. However the organization shall have a document release procedure that ensures only
approved cosmetic ingredient is issued to customers.

The organization is not required to determine and justify cosmetic ingredient stability.

8.7 Control of non-conforming outputs

The organization shall have a system for dealing with non-conforming cosmetic products, either
by release with written permission from the customer, return to the manufacturer or disposal.

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APPENDIX G Contributors to
the EFfCI GMP Guide and Standard

Members of the EFfCI GMP Working Group who prepared the 2005 edition
Johannes Gareiss LANXESS Distribution GmbH
Stephan Heck Cognis Deutschland GmbH & Co. KG
Torsten Henning Clariant GmbH
Ina Höfgen-Müller Merck KGaA
Stefan Knoop Symrise GmbH & Co. KG
George Mansveld Hercules International Ltd LLC
Volker Martin Zschimmer & Schwarz GmbH
Iain Moore Croda Chemicals Europe Ltd
Stefania Pescarolo MAPIC-ACFIS
Boris Pimentel DSM Nutritional Products
Peter Schindler Merck KGaA
Ralf-Peter Schuster Cognis Deutschland GmbH & Co. KG
Wibke Stelter Clariant GmbH
Peter Ungeheuer EFfCI
Marco Vassallo Res Pharma Srl

The 2008 revisions were prepared by

Severine Blondeau BASF Beauty Care Solutions France SAS
Helga Gaden Ciba Specialty Chemicals
Paola Granata MAPIC-AISPEC
Stephan Heck DSM Nutritional Products Ltd.
Bettina Kopp-Holtwiesche Cognis GmbH
George Mansveld Hercules International Ltd LLC
Iain Moore Croda Europe Ltd
Dominique Rain ASPA, Section INGRECOS
Martina Schindek DSM Nutritional Products Ltd.
Ralf-Peter Schuster Cognis GmbH
Wibke Stelter Clariant Produkte (Deutschland) GmbH
Peter Ungeheuer EFfCI
Eugenio Vallente BASF Beauty Care Solutions France SAS
Marco Vassallo FAR.CO.S. s.r.l.
Marie-Madeleine Vincent Rhodia Novecare

The 2010 revision was prepared by

Severine Blondeau BASF Beauty Care Solutions France SAS
George Mansveld Ashland Services BV
Iain Moore Croda Europe Ltd
Martina Schindek DSM Nutritional Products Ltd.
Wibke Stelter Clariant Produkte (Deutschland) GmbH
Peter Ungeheuer EFfCI
Wim Van den Broecke DSM Nutritional Products Ltd.
Marco Vassallo FAR.CO.S. s.r.l.

E F f C I G M P F O R C O S M E T I C I N G R E D I E N T S 2 0 1 7 • 53
 The 2012 revision was prepared by:
EFfCI
Severine Blondeau BASF Beauty Care Solutions France SAS
Iain Moore Croda Europe Ltd
Wibke Stelter Clariant Produkte (Deutschland) GmbH
Peter Ungeheuer EFfCI
Marco Vassallo FAR.CO.S. s.r.l.
Eugenio Valente BASF Beauty Care Solutions France SAS
Marie-Madeleine Vincent RHODIA NOVECARE
Pauline Rieux DSM Nutritional Products Ltd
Vincenzo Paolo Maria Rialdi Vevy Europe S.p.A
Stefan Knoop Symrise AG
Ulrich Fechtel Merck KGaA

FEBEA
Isabelle Orquevaux FEBEA
Pascal Gidoin L’Oreal
Jean Pierre Guidot L’Oreal
Cecile Poncon Pierre Fabre
Laurent Becaud Chanel
Nathalie Garnier Yves Rocher
Jean Baranger Chanel
Karine Lefort-Boc Yves Rocher

The 2017 revision was prepared by:

EFfCI
Raul Blanco Bazaco AENOR
Stephanie Bossy Intertek Certification France
Jean-Francois Cazaubon SEPPIC SA
Andrea Gross DSM Nutritional Products Ltd.
Karl Hensen Merck KGaA
Benoit Hun Stepan Europe S.A.S.
François Jodogne SGS Belgium NV
Stefan Knoop Symrise AG
Fabien Luciani Ashland Specialities France sarl
David Melchior BASF Personal Care and Nutrition GmbH
Iain Moore Croda Europe Ltd
Peter Radley Innospec Performance Chemicals
Vincenzo Paolo Maria Rialdi Vevy Europe S.p.A
Ulrike Schupmann BASF Personal Care and Nutrition GmbH
Peter Ungeheuer EFfCI
Marco Vassallo Complife Italia S.r.l.

PCPC
Harry Bennett Rutgers University – The State University of New Jersey
Joanne Nikitakis PCPC
Tim Parrent Mary Kay, Inc.

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