Specifities of the ISO 22716 standard Good Cosmetic Manufacturing Practices version 2007

13/10/2023

See the quiz "ISO 22716 requirements version 2007".

ISO 22716 version 2007 is the standard for guidelines on Good Manufacturing Practices for cosmetic products.

ISO 22716 is a standard (in substance) and guidelines (in content).

ISO 22716 requirements version 2007

The course T 23v07 ISO 22716 readiness version 2007 and its free demo without registration

The course T 43v07 ISO 22716 internal audit version 2007 and its free demo without registration

The training package T 83v07 ISO 22716 readiness and internal audit

1. ISO 22716 Structure

The ISO 22716 cosmetic Good Manufacturing Practices guidelines include 17 clauses:

Scope
Terms and definitions
Personnel
Premises
Equipment
Raw materials and packaging materials
Production
Finished products
Quality control laboratory
Treatment of product that is out of specification
Wastes
Subcontracting
Deviations
Complaints and recalls
Change control
Internal audit
Documentation

2. Terms

Terms and definitions in clause 2 are 36:

acceptance criteria
audit
batch
batch number
bulk product
calibration
change control
cleaning
complaint
contamination
consumables
contract acceptor
control
deviation
finished product
in-process control
internal audit
major equipment
maintenance
manufacturing operation
out-of-specification
packaging operation
packaging material
plant
premises
production
quality assurance
raw material
recall
reprocessing
return
sample
sampling
sanitization
shipment
waste

3 DOCUMENTATION

The requirements (recommendations) of the documentation are not specified, but in practice the necessary procedures can be:

Training (clause 3)
Responsibilities and authorities (clause 3)
Control of the working environment (clause 4)
Maintenance (clause 5)
Purchasing (clause 6)
Receipt (clause 6)
Identification and traceability (clause 6)
Production (clause 7)
Release (clause 8)
Laboratory (clause 9)
Inspection (clause 9)
Subcontracting (clause 12)
Deviations (clause 13)
Handling of complaints and recalls (clause 14)
Change control (clause 15)
Internal audit (clause 16)
Corrective action (clause 16)
Control of documents (clause 17)

Instructions (templates, records) which can be used:

process sheet
job description sheet
change notice
training certificate
prior learning assessment
measuring equipment verification range
procedure model
instruction model
certificate of conformity
list of subcontractors
supplier survey
subcontractor quality claim
quarterly subcontractor quality indicator
reception anomaly
shipping request
carrier claim
job sheet
maintenance record
maintenance worksheet
batch tracking sheet
inspection results
non-conformance sheet
customer deviation
internal auditor's list
audit plan
audit program
audit report

4. Cosmetic regulation clauses CE 1223/2009

CHAPTER I SCOPE, DEFINITIONS
- clause 1 Scope and objective
- clause 2 Definitions
CHAPTER II SAFETY, RESPONSIBILITY, FREE MOVEMENT
- clause 3 Safety
- clause 4 Responsible person
- clause 5 Obligations of responsible persons
- clause 6 Obligations of distributors
- clause 7 Identification within the supply chain
- clause 8 Good manufacturing practices
- clause 9 Free movement
CHAPTER III SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION
- clause 10 Safety assessment
- clause 11 Product information file
- clause 12 Sampling and analysis
- clause 13 Notification
CHAPTER IV RESTRICTIONS FOR CERTAIN SUBSTANCES
- clause 14 Restrictions for substances listed in the Annexes
- clause 15 Substances classified as CMR substances
- clause 16 Nanomaterials
- clause 17 Traces of prohibited substances
CHAPTER V ANIMAL TESTING
- clause 18 Animal testing
CHAPTER VI CONSUMER INFORMATION
- clause 19 Labelling
- clause 20 Product claims
- clause 21 Access to information for the public
CHAPTER VII MARKET SURVEILLANCE
- clause 22 In-market control
- clause 23 Communication of serious undesirable effects
- clause 24 Information on substances
CHAPTER VIII NON-COMPLIANCE, SAFEGUARD CLAUSE
- clause 25 Non-compliance by the responsible person
- clause 26 Non-compliance by distributors
- clause 27 Safeguard clause
- clause 28 Good administrative practices
CHAPTER IX ADMINISTRATIVE COOPERATION
- clause 29 Cooperation between competent authorities
- clause 30 Cooperation regarding verification of the product information files
CHAPTER X IMPLEMENTING MEASURES, FINAL PROVISIONS
- clause 31 Amendment of the Annexes
- clause 32 Committee procedure
- clause 33 Glossary of common ingredient names
- clause 34 Competent authorities, poison control centres or assimilated entities
- clause 35 Annual report on animal testing
- clause 36 Formal objection to harmonised standards
- clause 37 Penalties
- clause 38 Repeal
- clause 39 Transitional provisions
- clause 40 Entry into force and date of application
ANNEX I COSMETIC PRODUCT SAFETY REPORT
ANNEX II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS (1379)
ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN OUTSIDE THE RESTRICTIONS LAID DOWN (296)
ANNEX IV LIST OF COLOURING AGENTS THAT MAY BE PRESENT IN COSMETIC PRODUCTS (153)
ANNEX V LIST OF PRESERVATIVES PERMITTED IN COSMETIC PRODUCTS (59)
ANNEX VI LIST OF ULTRAVIOLET FILTERS ALLOWED IN COSMETIC PRODUCTS (30)
ANNEX VII SYMBOLS USED ON THE PACKAGING/CONTAINER
ANNEX VIII LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING
ANNEX IX PART A Repealed Directive with its successive amendments (referred to in clause 33)
ANNEX IX PART B List of time-limits for transposition into national law and application (referred to in clause 33)
ANNEX X MAPPING TABLE