Presentation is loading. Please wait.

Presentation is loading. Please wait.

Market Surveillance of Cosmetic Products in the Netherlands European Market Surveillance Programming Conference. March 10-11, 2005 Dr. Peter C. Bragt.

Similar presentations


Presentation on theme: "Market Surveillance of Cosmetic Products in the Netherlands European Market Surveillance Programming Conference. March 10-11, 2005 Dr. Peter C. Bragt."— Presentation transcript:

1 Market Surveillance of Cosmetic Products in the Netherlands European Market Surveillance Programming Conference. March 10-11, 2005 Dr. Peter C. Bragt

2 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 2 Outlines of presentation 1.Organization 2.Targets 3.Programming 4.Results 5.Points for discussion

3 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 3 Outlines of presentation 1.Organization 2.Targets 3.Programming 4.Results 5.Points for discussion

4 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

5 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 5 Outlines of presentation 1.Organization 2.Targets 3.Programming 4.Results 5.Points for discussion

6 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)

7 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 7 Inspections and samples cosmetic products Chem./microb. prod safety Cosmetics –Inspections 4904 (3%) 1158 –Samples 5950 (4.6%) tattoo dyes

8 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 8 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

9 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 9 Outlines of presentation 1.Organization 2.Targets 3.Programming 4.Results 5.Points for discussion

10 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 10 Vision Long-term program (3 years) Long-term program (3 years) Annual program (1 year) Annual program (1 year) Operational activity program Operational activity program Executive activity program Executive activity program Control Governmental Policy (EU+nat.) Governmental Policy (EU+nat.) Planning cycle VWA

11 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)

12 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 12 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

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

14 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 14 Outlines of presentation 1.Organization 2.Targets 3.Programming 4.Results 5.Points for discussion

15 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 15 Application of Administrative law 2003 Number of fines:8408 Value : 7,342,427.- Appeals: 10% Substantiated appeals: 25 (0.3%) Application of Criminal law 2003 Reports to public prosecutor:ca. 2000

16 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 16 Skin bleaching cosmetics Hydroquinone Mercury Corticosteroids Inspection results NL region SW, until Feb First inspection round: 67 inspections performed 57 legal measures (85%) Second inspection round: 42 re-inspections 11 legal measures (26%)

17 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

18 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 18 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 ( ) – In vitro SPF preferable – On agenda EU analytical group, ISO and CoE

19 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 19 Sun Protection Factor: in vitro vs. in vivo

20 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 20 Inspections of product information Non- compliant% OW% Total absent incomplete present 30 n.a

21 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 21 Inspections of product information n%OW% Producer51 Noncompliant Importer94 Noncompliant

22 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 22 Outlines of presentation 1.Organization 2.Targets 3.Programming 4.Results 5.Points for discussion

23 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 23 Elements for discussion 1. Latency in effectiveness of the directive (1) Product information requirement 1993/35/EEC low compliance (2) EU GMP guidelines 2005? (ISO GMP?) (3) Quantitative analytical methods for enforcement (e.g.fragrances) (4) ….. LegislationEnforcement

24 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 24 Elements for discussion 2.Cross border enforcement -1- % capacity Planning 2006 Administrative Cooperation Rapex Incidents January December

25 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 25 Elements for discussion 2.Cross border enforcement -2- Priority setting concerning request EU member state Low priorityHigh priority

26 EU Market Surveillance Programming Conference March 10-11, 2005 Dr. Peter C. Bragt 26 Elements for discussion 2.Cross border enforcement -3- Jkelkeleljeljljeljelejeljeljeljee Elkejljeljeljljeljeljeljeljeljeljelje Ej;je;ej;je;je;ej;eje;je;je;je;je;ej ljheklghekejhejklhelehelhelhel hkejgekjekjeklhelehelhelhele eljjekehklhehelwuklu33u3o33 3hj33hjklhewdlhlhlhlhlhllhelelj dhjdebnsacmj,mnklkopfelfj,eff fejbfeljllfewlfewlflflflfewhjkleikl ehklfeklfewklfewhklfewhklklfe 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 requestClear request

27 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 !!)


Download ppt "Market Surveillance of Cosmetic Products in the Netherlands European Market Surveillance Programming Conference. March 10-11, 2005 Dr. Peter C. Bragt."

Similar presentations


Ads by Google