Safety assessment of cosmetics in Europe: 47 tables
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Basel [u.a.]
Karger
2008
|
| Series: | Current problems in dermatology
36 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XX, 213 S. |
| ISBN: | 9783805586559 3805586558 |
Staff View
MARC
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| 245 | 1 | 0 | |a Safety assessment of cosmetics in Europe |b 47 tables |c authors Vera Rogiers and Marleen Pauwels |
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| 490 | 1 | |a Current problems in dermatology |v 36 | |
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| 650 | 4 | |a Recht | |
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| 650 | 4 | |a Cosmetics |x Toxicology |z Europe | |
| 650 | 4 | |a Cosmetics |x Analysis |z Europe | |
| 650 | 4 | |a Cosmetics |x Law and legislation |z Europe | |
| 650 | 4 | |a Cosmetics |x standards | |
| 650 | 4 | |a Consumer Product Safety |x legislation & jurisprudence | |
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Record in the Search Index
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|---|---|
| adam_text | Contents
List of abbreviations IX
Foreword XV
Preface
XVII
Chapter
1 :
Cosmetic Products and Their Current European Regulatory Framework
1
1.1
Introduction
2
1.2
The Cosmetic Products Directive
2
1.2.1
Definition of a Cosmetic Product
2
1.2.2
The Safety Prerequisite and Responsibilities
3
1.2.3
The Public Information Prerequisite
4
1.2.4
The Technical Information File Prerequisite
5
1.2.5
The Annexes to the Cosmetic Products Directive and the SCC(NF)P
5
1.2.6
The Animal Testing Ban for Cosmetics and Their Ingredients
6
1.2.7
Safety Assessment of Cosmetic Ingredients under the Cosmetic Products Directive
7
1.2.8
Proposal for a Recast of the Cosmetic Products Directive
9
a) Moving from a Directive to a Regulation
9
b) Introduction of a Set of Definitions
10
c) One Single European Notification and a Strengthened Market Control
10
d) New Provisions for CMR Substances
10
e) Introduction of Harmonised Standards
10
f) Clarifications on the Safety Assessment of Cosmetic Products
10
g)
INCI
Becomes Name of Common Ingredients Glossary
11
1.3
Relevant Vertical EULegislations
11
1.3.1
Impact of the Dangerous Substances Directive and REACH
11
a) General Provisions
11
b) Relevance for Cosmetics
13
1.3.2
Impact of the Dangerous Preparations Directive
15
a) General Provisions
15
b) Relevance for Cosmetics
15
1.3.3 EU
Legislation on Food Additives
16
a) General Provisions
16
b) Relevance for Cosmetics
16
1.3.4
Impact of the Biocidal Products Directive
17
a) General Provisions
17
b) Relevance for Cosmetics
17
1.3.5
Impact
of the Medicinal Products Directive
17
a) General Provisions
17
b) Relevance for Cosmetics
18
1.3.6
Impact of the
EU
Legislation on Detergents
18
a) General Provisions
18
b) Relevance for Cosmetics
18
1.3.7
Impact of the Plant Protection Directive and the
EU
Legislations on Medical Devices
19
a) General Provisions
19
b) Relevance for Cosmetics
19
1.3.8
Combined Impact of Relevant Vertical
EU
Legislations on Data Availability for a
Cosmetic Ingredient
19
1.4
Relevant Horizontal
EU
Legislations
21
1.4.1
Horizontal Provisions for the Protection of Animals
22
1.4.2
General Product Safety Directive
23
1.4.3
EU
Legislation on Prepackaged Products and Nominal Quantities
24
1.4.4
EU
Legislation on Aerosol Dispensers
25
1.5
References
26
Chapter
2:
Challenges Related to Cosmetic Safety Assessment
in the
EU
29
2.1
Introduction
30
2.2
Relevant Features of the General
EU
Risk Assessment Paradigm
30
2.2.1
Overview of the Classical Risk Assessment Process
30
2.2.2
Hazard Identification and Dose-Response Assessment
31
a) Determination of Physicochemical and Toxicological Properties
31
b) The NOAEL Value and the BMD Approach
34
c) Non-Threshold Effects
35
2.2.3
Exposure Assessment
36
a) General Principles
36
b) Exposure Levels per Cosmetic Product Type
36
c) Calculation of the Cosmetic Systemic Exposure Dosage
38
2.2.4
Risk Characterisation
39
a) Calculation of the Margin of Safety
39
b) Other Approaches Relevant to Cosmetic Safety Assessment
40
2.2.5
Risk Management, Risk Communication and Risk Perception
41
2.3
Actual Challenges for the European Cosmetic Safety Assessor
44
2.3.1
Moving Away from Animal Testing
44
2.3.2
Urgent Need for Appropriate Exposure Data
45
2.3.3
New Role of Raw Material Suppliers
46
2.3.4
The Need for Appropriate Training
47
2.3.5
Ethical Constraints in Human Testing
48
2.3.6
Special Problems for Small and Medium-Sized Enterprises
48
2.3.7
Consumer Concerns
48
2.4
References
49
Chapter
3:
Critical Analysis of the Safety Assessment of Cosmetic
Ingredients Performed at the European Level
58
3.1
Introduction
59
3.2
General Analysis of Published SCCCNFJP Opinions
(2000-2006) 60
3.2.1
Methodology
60
3.2.2
Number of Opinions
61
3.2.3
Ingredient Types
62
3.2.4
Success Rate
63
3.2.5
Content Comparison of Submissions Discussed in
2003
and
2006 64
a) Data Availability
65
b) Data Acceptance
67
c) Requested Additional Data
67
d) Combining Data Availability, Data Acceptance and Additionally Requested Data
67
VI Contents
3.2.6
The Interplay between Industry and the
SCCCNF)?
over the Years
69
a) Observations
69
b) Actions Taken by Colipa for Submitting Hair Dye-Related Dossiers
70
c) Organisation within the SCCP
71
d) Steps Taken by the
EU
Commission
71
3.3
Analysis of Three Contentious Areas in the
EU
Safety Assessment of Cosmetic Ingredients
72
3.3.1
Methodology
72
3.3.2
Identity and Physicochemistry
72
a) Detailed SCC(NF)P Requirements
72
b) Mostly Reported Shortcomings in SCCCNFJP Reports
73
3.3.3
The in vitro Dermal Absorption Study
74
a) Official Guidance, Including
SCCiWţP
Requirements
74
b) General Principles of the in vitro Dermal Absorption Study
74
c) Mostly Reported Shortcomings in
SCC(NF)P
Reports
76
d) The Use of Dermal Absorption Data in Margin of Safety Calculations
78
e) Additional in vitro Dermal Absorption Issues
79
f) Alternatives for in vitro Dermal Absorption Studies
81
3.3.4
Mutagenicity/Genotoxicity
82
a) Detailed SCCOSIF)? Requirements
82
b) Presence of Individual Studies in SCCCNFIP Reports
84
c) Mostly Reported Shortcomings in SCCfNF)? Reports
85
3.4
Discussion and Conclusions
86
3.5
References
88
Chapter
4:
Safety Assessment of Cosmetic Ingredients Present in
Technical Information Files of Finished Products
94
4.1
Introduction
95
4.2
Database Search for Safety Information on Cosmetic Ingredients
96
4.2.1
General Considerations
96
4.2.2
Useful Data Sources
97
a) Types of Data Sources
97
b) Free Information Sources on the Internet
98
c) Commercial Data Sources
102
d) Information Provided by the Ingredients Manufacturers)
105
4.2.3
The Quest for Safety Data in Practice
106
a) Identification of the Substance/Mixture
107
b) A
Free of Charge Internet Search
107
c) The Search in Commercial Databases (Payable)
109
4.2.4
Evaluation of Data Quality
109
4.3
Risk Assessment of Cosmetic Ingredients in Finished Cosmetic Products in the
EU
110
4.4
Discussion and Conclusions
112
4.5
References
113
Chapter
5:
The Cosmetic Technical Information File in Practice
115
5.1
Introduction
116
5.2
The Legal Requirements in Practice: A Proposal
117
5.2.1
Qualitative and Quantitative Composition of the Product
117
5.2.2
Physicochemistry, Microbiology and Purity of Ingredients and of the Finished Product
118
a) Physicochemical Data
118
b) Microbiological Checks
119
c) Physicochemical and Microbiological Stability
119
d) Purity and Impurity Profile
119
5.2.3
Manufacturing Method
120
5.2.4
Safety Assessment of the Finished Cosmetic Product
120
5.2.5
Name and Address of the Safety Assessor
121
5.2.6
Existing Data on Undesirable Effects on Human Health
121
5.2.7
Proof of the Effects Claimed
122
5.2.8
Data on Animal Testing
123
Contents
VII
5.3
Some Practical Remarks
123
5.4
Proposed Framework for a TIF
125
5.5
Discussion and Conclusions
126
5.6
References
127
Chapter
6:
The Use of Alternative Methods in the Safety Assessment of
Cosmetic Ingredients
129
6.1
Introduction
130
6.2
Materials and Methods
131
6.3
Animal Testing and 3-R Alternatives in SCCCNFJP Dossiers
131
6.3.1
Acute
Toxicity
131
a) Background
131
b) Acute Oral
Toxicity
Data in SCCCNFJP Opinions
133
6.3.2
Skin Irritation
134
a) Background
134
b) Skin Irritation Data in SCCCNF)? Opinions
135
6.3.3
Eye Irritation
136
a) Background
136
b) Eye Irritation Data in SCCCNF)? Opinions
137
6.3.4
Skin Sensitisation
138
a) Background
138
b) Skin Sensitisation Data in SCCCNF)? Opinions
140
6.3.5
Repeated Dose
Toxicity
Testing
142
a) Background
142
b) Repeated Dose
Toxicity
Studies in SCCfNF)? Reports
143
6.3.6
Toxicokinetics (Including Dermal Absorption)
144
6.3.7
Reproductive
Toxicity
144
a) Background
144
b) Reproductive
Toxicity
Studies in SCCfNFJP Reports
145
63.8
Mutagenicity/Oenotoxicity and Carcinogenicity
146
a) Background
146
b) Mutagenicity/Genotoxiciry Studies in
SCCCNFJP
Reports
146
6.3.9
Photo-Induced
Toxicity
147
a) Background
147
b) Photo-Induced
Toxicity
Studies in
SCC(NF)P
Reports
149
6.4
Cosmetic Animal Numbers Placed into Perspective
149
6.4.1
Animal Numbers and
Timeframe
for Cosmetic Ingredients Testing
149
6.4.2
Projected Animal Numbers and
Timeframe
under REACH
153
6.5
Discussion and Conclusions
154
6.6
References
і
58
Chapter
7:
Headlines of Safety Assessment of Cosmetics in Europe and
Future Perspectives
166
Appendices
183
Appendix
1 :
The Transposition of Directive 76/768/EEC into Belgian Law: A Practical Example
184
Appendix
2:
A. List of studied SCCfNF)? opinions
188
B. Opinions in which more than one compound is discussed
189
C. List of ingredients discussed in multiple opinions
190
Appendix
3 :
Proposed Framework for a Cosmetic Technical Information File
191
Appendix
4:
Data Input Forms: General Information
208
Subject Index
210
VIII
Contents
|
| any_adam_object | 1 |
| author | Rogiers, Vera Pauwels, Marleen |
| author_GND | (DE-588)13630270X (DE-588)136302718 |
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| callnumber-subject | RA - Public Medicine |
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| dewey-full | 646.720289 646.7/20289 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 646 - Sewing, clothing & personal living |
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| dewey-search | 646.720289 646.7/20289 |
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| dewey-tens | 640 - Home and family management |
| discipline | Chemie / Pharmazie Agrar-/Forst-/Ernährungs-/Haushaltswissenschaft / Gartenbau Medizin |
| format | Book |
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| geographic | Europa swd Europa Europa (DE-588)4015701-5 gnd |
| geographic_facet | Europa |
| id | DE-604.BV035205009 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-09T21:28:32Z |
| institution | BVB |
| isbn | 9783805586559 3805586558 |
| language | English |
| lccn | 2008033473 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-017011407 |
| oclc_num | 845385243 |
| open_access_boolean | |
| owner | DE-12 DE-355 DE-BY-UBR DE-Er8 |
| owner_facet | DE-12 DE-355 DE-BY-UBR DE-Er8 |
| physical | XX, 213 S. |
| publishDate | 2008 |
| publishDateSearch | 2008 |
| publishDateSort | 2008 |
| publisher | Karger |
| record_format | marc |
| series | Current problems in dermatology |
| series2 | Current problems in dermatology |
| spelling | Rogiers, Vera Verfasser (DE-588)13630270X aut Safety assessment of cosmetics in Europe 47 tables authors Vera Rogiers and Marleen Pauwels Basel [u.a.] Karger 2008 XX, 213 S. txt rdacontent n rdamedia nc rdacarrier Current problems in dermatology 36 Includes bibliographical references and index Europäische Union idszbz Kosmetikum idszbz Kosmetikum swd Produktsicherheit idszbz Produktsicherheit swd Qualitätssicherung idszbz Recht Cosmetics Safety measures Europe Cosmetics Toxicology Europe Cosmetics Analysis Europe Cosmetics Law and legislation Europe Cosmetics standards Consumer Product Safety legislation & jurisprudence Consumer Product Safety standards Kosmetikum (DE-588)4032552-0 gnd rswk-swf Produktsicherheit (DE-588)4246587-4 gnd rswk-swf Europa swd Europa Europa (DE-588)4015701-5 gnd rswk-swf Europa (DE-588)4015701-5 g Kosmetikum (DE-588)4032552-0 s Produktsicherheit (DE-588)4246587-4 s 1\p DE-604 Pauwels, Marleen Verfasser (DE-588)136302718 aut Current problems in dermatology 36 (DE-604)BV002570447 36 Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017011407&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Rogiers, Vera Pauwels, Marleen Safety assessment of cosmetics in Europe 47 tables Current problems in dermatology Europäische Union idszbz Kosmetikum idszbz Kosmetikum swd Produktsicherheit idszbz Produktsicherheit swd Qualitätssicherung idszbz Recht Cosmetics Safety measures Europe Cosmetics Toxicology Europe Cosmetics Analysis Europe Cosmetics Law and legislation Europe Cosmetics standards Consumer Product Safety legislation & jurisprudence Consumer Product Safety standards Kosmetikum (DE-588)4032552-0 gnd Produktsicherheit (DE-588)4246587-4 gnd |
| subject_GND | (DE-588)4032552-0 (DE-588)4246587-4 (DE-588)4015701-5 |
| title | Safety assessment of cosmetics in Europe 47 tables |
| title_auth | Safety assessment of cosmetics in Europe 47 tables |
| title_exact_search | Safety assessment of cosmetics in Europe 47 tables |
| title_full | Safety assessment of cosmetics in Europe 47 tables authors Vera Rogiers and Marleen Pauwels |
| title_fullStr | Safety assessment of cosmetics in Europe 47 tables authors Vera Rogiers and Marleen Pauwels |
| title_full_unstemmed | Safety assessment of cosmetics in Europe 47 tables authors Vera Rogiers and Marleen Pauwels |
| title_short | Safety assessment of cosmetics in Europe |
| title_sort | safety assessment of cosmetics in europe 47 tables |
| title_sub | 47 tables |
| topic | Europäische Union idszbz Kosmetikum idszbz Kosmetikum swd Produktsicherheit idszbz Produktsicherheit swd Qualitätssicherung idszbz Recht Cosmetics Safety measures Europe Cosmetics Toxicology Europe Cosmetics Analysis Europe Cosmetics Law and legislation Europe Cosmetics standards Consumer Product Safety legislation & jurisprudence Consumer Product Safety standards Kosmetikum (DE-588)4032552-0 gnd Produktsicherheit (DE-588)4246587-4 gnd |
| topic_facet | Europäische Union Kosmetikum Produktsicherheit Qualitätssicherung Recht Cosmetics Safety measures Europe Cosmetics Toxicology Europe Cosmetics Analysis Europe Cosmetics Law and legislation Europe Cosmetics standards Consumer Product Safety legislation & jurisprudence Consumer Product Safety standards Europa |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017011407&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV002570447 |
| work_keys_str_mv | AT rogiersvera safetyassessmentofcosmeticsineurope47tables AT pauwelsmarleen safetyassessmentofcosmeticsineurope47tables |