Market Surveillance of Cosmetic Products in the Netherlands

European Market Surveillance Programming Conference. March 10-11, 2005

Dr. Peter C. Bragt

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 2

Outlines of presentation

1. Organization2. Targets3. Programming4. Results5. Points for discussion

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 3

Outlines of presentation

1. Organization2. Targets3. Programming4. Results5. Points for discussion

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 4

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 5

Outlines of presentation

1. Organization2. Targets3. Programming4. Results5. Points for discussion

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 6

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 7

Inspections and samples cosmetic products 2005

-----------------------------------------------------------------------------------------Chem./microb. prod safety Cosmetics

-----------------------------------------------------------------------------------------– Inspections 4904 (3%) 1158

– Samples 5950 (4.6%) 1080+ 2000 tattoo

dyes-----------------------------------------------------------------------------------------

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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

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Outlines of presentation

1. Organization2. Targets3. Programming4. Results5. Points for discussion

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 10

VisionVision

Long-termprogram(3 years)

Long-termprogram(3 years)

Annualprogram(1 year)

Annualprogram(1 year)

Operationalactivity program

Operationalactivity program

Executiveactivity program

Executiveactivity programControlControl

Governmental Policy (EU+nat.)

Governmental Policy (EU+nat.)

Planning cycle VWA

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 11

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)

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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 GMP3. Quality and safety data are available and valid4. ‘Informed choice’ for consumer: labeling in compliance

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 13

Activities cosmetic products 2005 and 2006

Child cosmeticsDetection of allergenic ingredientsHair dyesAfro cosmetics labelingAnnex 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 14

Outlines of presentation

1. Organization2. Targets3. Programming4. Results5. Points for discussion

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 15

Application of Administrative law 2003

Number of fines : 8408Value : € 7,342,427.-Appeals : 10%Substantiated appeals : 25 (0.3%)

Application of Criminal law 2003Reports to public prosecutor: ca. 2000

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Skin bleaching cosmeticsHydroquinoneMercuryCorticosteroids

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 17

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

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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

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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 20

Inspections of product information 2003-4 Non- compliant % OW %

--------------------------------------------------------------------Total 145 100 69 70 70

absent 67 49 73 incomplete 33 21 64 present 30 n.a. 15--------------------------------------------------------------------

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Inspections of product information 2003-4

n % OW %

---------------------------------------------------------------

Producer 51

Noncompliant 30 60 20 39

Importer 94

Noncompliant 70 74 50 53

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Outlines of presentation

1. Organization2. Targets3. Programming4. Results5. Points for discussion

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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 Enforcement

1993 2005

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Elements for discussion

2. Cross border enforcement -1- % capacity

100

85

Planning 2006

Administrative Cooperation

Rapex

IncidentsJanuary December

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Elements for discussion

2. Cross border enforcement -2-

Priority setting concerning request EU member state

Low priority High priority

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Elements for discussion

2. Cross border enforcement -3-

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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..

‘Fuzzy’ request Clear request

EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 27

Elements for discussion

2. Cross border enforcement -4-

Suggestions - 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 !!)