EFfCI GMP

Position Paper

Guidance on the content and

layout of a Cosmetic Ingredient
Certificate of Analysis
Version 2020

Page 1 of 5 April 2020

 Background
Suppliers of Cosmetic Ingredients are required to issue Certificates of Analysis with
the delivery of their products (reference Section 8.6 EFfCI GMP for Cosmetic
Ingredients). This document provides guidance on the content of a Cosmetic
Ingredient Certificate of Analysis.

Definition
The Certificate of Analysis is primarily a means of communicating the analytical results
on the batch or lot. Other statements may be included where relevant to ensuring the
quality of the material.

Basis of Certificate of Analysis

There are three relevant documents which can aid Cosmetic Ingredient Suppliers in
the design and layout of a Certificate of Analysis. None of these are specific for
cosmetic ingredients but have many desirable features. They are:
1. EN 10204 Certificates for Metal Products
2. IPEC-Federation Certificate of Analysis Guide for Pharmaceutical Excipients
3. Appendix 6 of the SCCS notes of guidance for the testing of cosmetic
ingredients and their safety evaluation, 10th Revision.
These documents contain many common features and recommendations, some of
which are applicable to materials destined for use in cosmetics. However, some were
defined for other industries and applications and contain additional requirements
which are not appropriate for cosmetic ingredients, notably:
1. EN10204 was designed for metal products and is relatively unknown outside
of Europe.
2. The IPEC-Federation Guide contains recommendations which are required for
the use of a material in pharmaceutical drug products, many of which are not
appropriate for cosmetic ingredients.
3. In the SCCS notes of guidance there are recommendations for the
Certificates of Analysis which are provided with substances that are to be
used as reference standards and therefore contain other requirements to
assure the quality of the substance for that purpose.

Recommendations for Contents of Cosmetic Ingredient Certificates of

Analysis
EFfCI has taken note of these standards and guides and makes the following
recommendations for the content of a Cosmetic Ingredient Certificate of Analysis.

The Certificate of Analysis for a cosmetic ingredient should include:

1. The name and address of the company responsible for issuing the CofA,
2. A unique identifier for the product, for example the item number or product code
of the ingredient,
3. The batch or lot number,
4 The date of the release of the batch, or date when the batch has been retested,
5 The Expiry or Retest Date, or, the period of time until the Expiry or next retest
date is reached,
6 The specified parameters and the analytical results,
7. A reference to the test procedure used, including the acceptance criteria (limits
and units of measure),
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 8 An indication if an analytical result was obtained from a statistically based
testing program,
9 The quality unit role who approved the CofA.

Where the certificate of analysis comprises more than one page, each page of the
CofA should clearly be referenced to the batch in question.

The following may be included on a Certificate of Analysis,

1. The name of the ingredient
2. The date of manufacture
3. An indication that each result is in compliance with the specification limits for that
test
4. Any special conditions required to maintain the quality of the cosmetic ingredient
(e.g. temperature, humidity, reduced oxygen contact etc.)
5. Customer details, for example; their name, purchase order number, material
name/identity
6. Delivery details, for example, quantity delivered
7. INCI name (if one has been assigned)
8. If a management system in accordance with EFfCI GMPs was used to in the
manufacture of the batch
9. If the cosmetic ingredient is supplied by a re-packer or trader, the certificate
should show the name, and address of the re-packer/trader and a reference to
the original manufacturer who issued the original batch CoA.

Guidance on the minimum contents of a Certificate of Analysis

Origin of the Certificate
Traceability is a key requirement throughout the EFfCI GMP for cosmetic ingredients.
Therefore, it is important that the origin of the material can be traced back to the
original manufacturer. This begins with a clear definition of which organisation
performed the Analysis and released the batch issued the Certificate of Analysis. This
should be the supplier.

Batch traceability
Equally the results have to be assigned to a specific batch or lot of material. The
Certificate should indicate the batch or lot number uniquely.

Dates
Many dates may be indicated on the Certificate, but in each case, it should be clear
what the date refers to, for example:

Retest date:
The definition in the EFfCI GMP for Cosmetic Ingredients is:
The date beyond which the cosmetic ingredient should not be used without
further appropriate re-examination.
This repeated batch release analysis should demonstrate that the product still
conforms to the specification.

Expiry date:
The definition in the EFfCI GMP for Cosmetic Ingredients is:
The date beyond which, a product may no longer conform to relevant
specifications.
Expiry date or expiration date is the date a product is expected to be no longer
usable for the named purpose and may only be suitable for disposal. It is
uncommon for cosmetic ingredients to be assigned an expiry interval but may be
assigned for ingredients which have a short stability interval e.g. ingredients
originally intended as food ingredients.
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 Normally the organisation holding a batch which has expired can test it to check
if it still meets specification, and if so, they may be able to immediately use the
batch.

Shelf life:
Use of this term should avoided as it may refer to retest interval or expiry interval,
or indeed some other interval.

Many dates can be included on the CofA. It should be clear what these dates refer to.
Each date should be stated using an unambiguous date format so that readers do not
confuse the months and days for example in US and EU date formats (e.g.: month
reported as shortened name).

Test Methods and Results

Reference should be made to each test method used. Best practice is to reference the
official test method or an international standard monograph and or norm (e.g. USPNF,
JSQI, ASTM, Ph Eur, ISO) (e.g. compendia chapter or DIN reference) to aid
traceability The details of the method may be described in a separate document, which
allows the user of the Certificate to perform their own confirmation testing using the
same method.

Actual results on the batch or lot in question should be reported.

If the results are determined by statistical methods, then this should be made clear on
the Certificate. Statistical methods include checking the parameter periodically, for
example once a year rather than on every batch or testing some fraction of the number
of batches produced. In these cases, the result should not be numeric but a statement
of conformance to the limits. The use of a statistical method may be indicated in a
footnote on the CofA.

Results may be quantitative (numerical) or qualitative (Pass/Fail).

Any units of measurement should be quoted where the method has a quantitative
result.

Specifications and certificates of analysis should have the same parameters and limits.

Results should be reported along with the specification requirements for that test.
The same decimal digits for result and acceptance limit should be used.

Approval of the CofA

The EFfCI GMP for cosmetic ingredients requires that the Quality unit is responsible for
the content and approval of the certificate of analysis. The role, or person responsible
for this approval should be indicated on the CofA. If a person is named then the role
should also be indicated and in all cases the affiliation to the Quality Unit should be
clear.
Optional content for a Cosmetic Ingredient Certificate of Analysis
Date of Manufacture
The Supplier should define in their quality management system how this date is
defined. It may the point at which manufacture starts, finishes or some other date.

Recertification
This is a process which extends the retest period. As batches come close to the first
retest date, they can be examined again using a combination of internal data and
product knowledge, and repeat analysis to recertify the batch. Normally when a retest
date is assigned, every batch will be recertified at least once. The assignment of the
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 next retest interval will depend on the latest test results in relation to specification limits
and on experience with the product. A new CofA with updated results may be issued.

When a batch is recertified a new retest date or retest period should be displayed on
the certificate of analysis.

Signatures
A signature (physical or electronic) is not essential. An electronic one giving equivalent
assurance to a physical one may be included as part of the Certificate. Measures to
ensure electronic signatures are secure and attributable to the named individual
include having unique and personal logins and passwords to the applications
producing certificates of analysis.

Other Information
It is preferable to keep the contents of the certificate of analysis to the results of
analytical testing and the necessary information to allow traceability (origin, results and
records etc.).

Other information may be required by customers, but these are better managed in
separate documents as they can otherwise increase the size of the document and act
to slow down the customer goods receipt processes.

Page 5 of 5 April 2020