Market Surveillance of Cosmetic Products
in the Netherlands
European Market Surveillance Programming Conference.
March 10-11, 2005
Dr. Peter C. Bragt
Outlines of presentation
1.
2.
3.
4.
5.
Organization
Targets
Programming
Results
Points for discussion
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
2
Outlines of presentation
1.
2.
3.
4.
5.
Organization
Targets
Programming
Results
Points for discussion
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
3
Food & Consumer Product Safety Authority
(VWA)
– Competent authority for food, non-food consumer products and
veterinary public health
– Agency of Ministry of Agriculture, Nature & Food Quality
– One single organization operating nation-wide
– 1 Central office in Den Haag
– 5 regional offices (inspectorates)
– Financial resources from Ministry of Health, Welfare & Sports and
Ministry of Agriculture, Nature and Food Quality
– Budget 2006: 150 M€
– Number of personnel 2006: 1805
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
4
Outlines of presentation
1.
2.
3.
4.
5.
Organization
Targets
Programming
Results
Points for discussion
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
5
Annual contract VWA - Minister of Health
1. Quantitative targets 2005
• Inspections (n = 155,000)
• Samples investigated (n = 130,000)
2. Qualitative targets = effectiveness
• Demonstrable effects of enforcement activities
(reduction in number of violations or accidents)
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Inspections and samples cosmetic products
2005
----------------------------------------------------------------------------------------Chem./microb. prod safety
Cosmetics
----------------------------------------------------------------------------------------– Inspections
4904 (3%)
1158
– Samples
5950 (4.6%)
1080
+ 2000 tattoo dyes
-----------------------------------------------------------------------------------------
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Number of companies
Total of inspection points for chemical product safety:
~20,000 producers, importers, distributors
Cosmetic companies: ~4,000
P.M.: individual retailers not included
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Outlines of presentation
1.
2.
3.
4.
5.
Organization
Targets
Programming
Results
Points for discussion
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
9
Governmental
Policy (EU+nat.)
Vision
Long-term
program
(3 years)
Annual
program
(1 year)
Operational
activity program
Executive
activity program
Control
Planning cycle VWA
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
10
Elements for programming
Risk based (= expected health risk or non-compliance)
–
–
–
–
–
–
Changes of directive 76/768/EEC (adaptations, amendments)
Technological developments (new products, new habits or trends)
Politic or public concern (‘perceived’ risk: e.g. UV filters - hormonal)
Consumer complaints (e.g. depilatories)
RAPEX notifications
Enhanced risk substances or products (skin bleaching, depilatories, nail
products)
– Vulnerable groups in the population (e.g. babies, elderly)
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Safe cosmetic products in EU market
“Diamond” of compliance:
1. Finished cosmetic product and ingredients evaluated for aspect of
safety
2. Cosmetic products produced under GMP
3. Quality and safety data are available and valid
4. ‘Informed choice’ for consumer: labeling in compliance
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Activities cosmetic products 2005 and 2006
Child cosmetics
Detection of allergenic ingredients
Hair dyes
Afro cosmetics labeling
Annex II CMR substances (nitrosamines, ….)
Inspections of product information (‘dossier’)
Public information on adverse effects and hazardous substances
(Setup of system for hygiene control of tattooing and piercing)
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
13
Outlines of presentation
1.
2.
3.
4.
5.
Organization
Targets
Programming
Results
Points for discussion
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
14
Application of Administrative law 2003
Number of fines
Value
Appeals
Substantiated appeals
:
:
:
:
8408
€ 7,342,427.10%
25 (0.3%)
Application of Criminal law 2003
Reports to public prosecutor: ca. 2000
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Skin bleaching cosmetics
Hydroquinone
Mercury
Corticosteroids
Inspection results NL region SW, until Feb. 2002
First inspection round:
67 inspections performed
57 legal measures (85%)
Second inspection round:
42 re-inspections
11 legal measures (26%)
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Survey nitrosamines in cosmetic products 2003
Nitrosamines detected in
18% of samples (n=130)
12% > limit of determination
 legal measure
http://www.vwa.nl/download/rapporten/productveiligheid/nitrosaminen_in_cosmetica.pdf
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Sun Protection Factor: survey 2003
– 58 sunscreen products sampled from market
– 19 had overdeclared SPF (> 25% of measured
with in vivo Colipa method)
– Very costly survey (€ 150.000)
– In vitro SPF preferable
– On agenda EU analytical group, ISO and CoE
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Sun Protection Factor: in vitro vs. in vivo
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Inspections of product information 2003-4
Noncompliant %
OW %
-------------------------------------------------------------------Total 145
100
69
70
70
absent
67
49
73
incomplete
33
21
64
present
30
n.a.
15
-------------------------------------------------------------------EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Inspections of product information 2003-4
n
%
OW %
--------------------------------------------------------------Producer
51
Noncompliant
30
Importer
94
Noncompliant
70
60
20
39
74
50
53
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Outlines of presentation
1.
2.
3.
4.
5.
Organization
Targets
Programming
Results
Points for discussion
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
22
Elements for discussion
1. ‘Latency’ in effectiveness of the directive
(1) Product information requirement 1993/35/EEC low compliance 2003-4
(2) EU GMP guidelines  2005? (ISO GMP?)
(3) Quantitative analytical methods for enforcement (e.g.fragrances)
(4) …..
Legislation
1993
Enforcement
2005
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Elements for discussion
2. Cross border enforcement -1% capacity
100
85
Administrative Cooperation
Rapex
Incidents
Planning 2006
January
EU Market Surveillance Programming Conference March 10-11, 2005
December
Dr. Peter C. Bragt
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Elements for discussion
2. Cross border enforcement -2Priority setting concerning request EU member state
Low priority
High priority
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Elements for discussion
2. Cross border enforcement -3Jkelkeleljeljljeljelejeljeljeljee
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‘Fuzzy’ request
Clear request to EU
competent authority
concerning a cosmetic
product which violates the
harmonized EU legislation.
The product is X from
company Y. Batch code Z.
Laboratory findings NNN.
Labeling problem MMM
Fraternal regards, P..
Clear request
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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Elements for discussion
2. Cross border enforcement -4Suggestions
- Foster mutual trust, understanding and interest
- Know each other, ask questions, exchange information, learn mutually
- Provide clear data and requests concerning enforcement activities
- Treat as high priority, unless indicated otherwise
- Create adequate mechanisms within the planning cycle
- Report back in most convenient or desirable manner
- Maintain confidentiality (according to national enforcement legal requirements)
- Exchange enforcement plans already in the DRAFT phase (t -11 months !!)
EU Market Surveillance Programming Conference March 10-11, 2005
Dr. Peter C. Bragt
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