1. TAIEX WORKSHOP Introduction of EU Legislation on Cosmetic Products (INT MARKT 61190) Belgrade, 22-23 February 2016 CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD Experience of BULGARIA Dimitar Dimitrov, M.D. Ministry of Health Ministry of Health

2. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD TRANSPOSITION OF THE LEGISLATION (Directive 76/768/EEC) LAW FOR THE HEALTH LAW FOR THE HEALTH Definition of cosmetic product, according Directive 76/768/EEC, main texts of Directive 95/17/EC (permission requirements), legal basis for issuing of Ordinance for cosmetic products Definition of cosmetic product, according Directive 76/768/EEC, main texts of Directive 95/17/EC (permission requirements), legal basis for issuing of Ordinance for cosmetic products

3. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD SECONDARY LEGISLATION Ordinance No 26/2001 for the requirements of cosmetic products Ordinance No 26/2001 for the requirements of cosmetic products Transition period for implementation – 2 years (entry into force September 2003) Transition period for implementation – 2 years (entry into force September 2003) Ordinance No 36/2005 for the requirements of cosmetic products Ordinance No 36/2005 for the requirements of cosmetic products Many amendments – till 2013 Many amendments – till 2013

4. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD SECONDARY LEGISLATION Ordinance No 36/2005 for the requirements of cosmetic products Ordinance No 36/2005 for the requirements of cosmetic products The ordinance transposes into the Bulgarian legislation all EU cosmetic directives: The ordinance transposes into the Bulgarian legislation all EU cosmetic directives: Directive 76/768/EEC (main text and annexes) Directive 76/768/EEC (main text and annexes) Directives 95/17/EC (main text and annex) and 2006/81/EC Directives 95/17/EC (main text and annex) and 2006/81/EC Directives 80/1335/ЕЕС, 82/434/ЕЕС, 83/514/ЕЕС, 85/490/ЕЕС, 93/73/ЕЕС, 95/32/ЕС and 96/45/ЕС (methods of analyses) Directives 80/1335/ЕЕС, 82/434/ЕЕС, 83/514/ЕЕС, 85/490/ЕЕС, 93/73/ЕЕС, 95/32/ЕС and 96/45/ЕС (methods of analyses) Recommendation 2006/647/EC (sunscreen products) Recommendation 2006/647/EC (sunscreen products)

5. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD LEGISLATION /picture now/ REGULATION (EC) No 1223/2009 on cosmetic products REGULATION (EC) No 1223/2009 on cosmetic products LAW FOR THE HEALTH LAW FOR THE HEALTH Definition of cosmetic product, responsible person, manufacturer, distributor and importer according REGULATION (EC) No 1223/2009 on cosmetic products Definition of cosmetic product, responsible person, manufacturer, distributor and importer according REGULATION (EC) No 1223/2009 on cosmetic products Competent Authorities Competent Authorities Poison centre Poison centre

6. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD LEGISLATION /picture now/ LAW FOR THE HEALTH LAW FOR THE HEALTH Labelling on Bulgarian language according to art. 19 (5) of the Regulation (EC) No 1223/2009 Labelling on Bulgarian language according to art. 19 (5) of the Regulation (EC) No 1223/2009 Product Information File on Bulgarian language according to art. 11 (3) of the Regulation (EC) No 1223/2009 Product Information File on Bulgarian language according to art. 11 (3) of the Regulation (EC) No 1223/2009 Penalties Penalties Legal basis for issuing of Ordinance for cosmetic products Legal basis for issuing of Ordinance for cosmetic products

7. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD SECONDARY LEGISLATION Ordinance No 14/2014 for the requirements… of cosmetic products Ordinance No 14/2014 for the requirements… of cosmetic products The ordinance: The ordinance: Transposes into the Bulgarian legislation cosmetic directives 80/1335/ЕЕС, 82/434/ЕЕС, 83/514/ЕЕС, 85/490/ЕЕС, 93/73/ЕЕС, 95/32/ЕС and 96/45/ЕС (methods of analyses) Transposes into the Bulgarian legislation cosmetic directives 80/1335/ЕЕС, 82/434/ЕЕС, 83/514/ЕЕС, 85/490/ЕЕС, 93/73/ЕЕС, 95/32/ЕС and 96/45/ЕС (methods of analyses) Gives detailed rules for indication of the information according to art. 19 (4) of REGULATION (EC) No 1223/2009 on cosmetic products Gives detailed rules for indication of the information according to art. 19 (4) of REGULATION (EC) No 1223/2009 on cosmetic products Gives requirements for the efficacy of sunscreen products according Recommendation 2006/647/EC (sunscreen products) Gives requirements for the efficacy of sunscreen products according Recommendation 2006/647/EC (sunscreen products)

8. BORDERLINE PRODUCTS, NON – COSMETIC CLAIMS COMPETENT AUTHORITIES MINISTRY OF HEALTH MINISTRY OF HEALTH State Health Control Directorate State Health Control Directorate 28 REGIONAL HEALTH INSPECTORATES 28 REGIONAL HEALTH INSPECTORATES

9. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD COMPETENT AUTHORITIES 28 REGIONAL HEALTH INSPECTORATES 28 REGIONAL HEALTH INSPECTORATES Structures within Regional Health Inspectorates, with competencies on cosmetic products: Structures within Regional Health Inspectorates, with competencies on cosmetic products: State Health Control Department, within Public Health Directorate. State Health Control Department, within Public Health Directorate. Number of state inspectors – 364 (they have also activities in many other areas and are not responsible only for the cosmetic products) Number of state inspectors – 364 (they have also activities in many other areas and are not responsible only for the cosmetic products) Laboratories for chemical and microbiological analysis, within Laboratory Measurements Directorate Laboratories for chemical and microbiological analysis, within Laboratory Measurements Directorate

10. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD COMPETENT AUTHORITIES MINISTRY OF HEALTH MINISTER DEPUTY MINISTER PUBLIC HEALTH CHIEF STATE HEALTH INSPECTOR STATE HEALTH CONTROL DIRECTORATE 28 REGIONAL HEALTH INSPECTORATES National Center on Public Health and Analyses Cosmetic Products Sector Others Sectors Chemical laboratory Microbiological laboratory

11. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD Other Department Communicable Disease Surveillance Directorate Communicable Disease Surveillance Directorate Epidemiological Control Department Department Public Health Directorate MedicalMeasurementsDepartmentMedicalMeasurementsDepartment DIRECTORDIRECTOR GENERAL ADMINISTRATION Administrative, Financial and Legal Services Directorate GENERAL ADMINISTRATION Administrative, Financial and Legal Services Directorate SPECIALIZED ADMINISTRATION Health Prevention and Promotion Department Health Prevention and Promotion Department LaboratoryMeasurementsDirectorateLaboratoryMeasurementsDirectorate State Health Control DepartmentState Department

12. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD MAIN CHALLENGES IN TRANSITION PERIOD From premarket control to in-market control From premarket control to in-market control Safety assessment Safety assessment Safety assessors Safety assessors Good manufacturing practice Good manufacturing practice Cosmetovigilance Cosmetovigilance

13. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD IMPLEMENTATION OF EU COSMETIC LEGISLATION Experience during transition period and first years of EU membership Experience during transition period and first years of EU membership Practical examples Practical examples Main problems Main problems

14. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD ANNUAL PLANNING Every year MoH (before the end of previous year) gives an Instruction (National plan) to Regional Inspectorates for planning their annual control activities, incl. in the field of cosmetic products Every year MoH (before the end of previous year) gives an Instruction (National plan) to Regional Inspectorates for planning their annual control activities, incl. in the field of cosmetic products Each of 28 Regional Inspectorates has to elaborate its own annual plan, on the basis of MoH’s National instruction (plan) and regional priorities, circumstances and experience Each of 28 Regional Inspectorates has to elaborate its own annual plan, on the basis of MoH’s National instruction (plan) and regional priorities, circumstances and experience

15. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD ANNUAL PLANNING The MoH’s Instructions have four components: The MoH’s Instructions have four components: General priorities for control activities in the field of cosmetic products for respective year; General priorities for control activities in the field of cosmetic products for respective year; Requirements for routine control (“normal” surveillance), incl.: Requirements for routine control (“normal” surveillance), incl.: requirements for minimal quantity of laboratory testing of cosmetic products placed on the market requirements for minimal quantity of laboratory testing of cosmetic products placed on the market requirements for minimal quantity of inspection (check visit) in the establishments for cosmetic products which are under control of Regional Inspectorates (enterprises, storehouses and supermarkets/shops, hairdressing and beauty salons and studios, etc.) requirements for minimal quantity of inspection (check visit) in the establishments for cosmetic products which are under control of Regional Inspectorates (enterprises, storehouses and supermarkets/shops, hairdressing and beauty salons and studios, etc.) Thematic checks-up (more detailed control/examination) (at least one per year) Thematic checks-up (more detailed control/examination) (at least one per year)

16. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD NATIONAL INSTRUCTION (PLAN) of MoH for 2008 (summary) Five general priorities for control activities Five general priorities for control activities Requirements for routine control (“normal” surveillance) Requirements for routine control (“normal” surveillance) Requirements for minimal quantity of laboratory testing of cosmetic products put on the market Requirements for minimal quantity of laboratory testing of cosmetic products put on the market Microbiological analysis - 6 samples every three months for each of 28 Regional Inspectorates (totally 672 samples in 2008 for the whole country); Microbiological analysis - 6 samples every three months for each of 28 Regional Inspectorates (totally 672 samples in 2008 for the whole country); Chemical analysis Chemical analysis restricted substances - 31 samples every three months (totally 124 samples in 2008 for the whole country) (13 substances in 7 categories cosmetic products) restricted substances - 31 samples every three months (totally 124 samples in 2008 for the whole country) (13 substances in 7 categories cosmetic products) banned substances - 2 samples every three months for each of 28 Regional Inspectorates (totally 224 samples in 2008 for the whole country) (4 substances in 2 categories cosmetic products) banned substances - 2 samples every three months for each of 28 Regional Inspectorates (totally 224 samples in 2008 for the whole country) (4 substances in 2 categories cosmetic products)

17. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD NATIONAL INSTRUCTION (PLAN) of MoH for 2008 (summary) Requirements for minimal quantity of inspection (check visit) in the establishments for cosmetic products which are under control of Regional Inspectorates: enterprises (2 times per year), storehouses (1 time per year) and supermarkets/shops (no obligatory requirements), hairdressing and beauty salons and studios (2 times per year) Requirements for minimal quantity of inspection (check visit) in the establishments for cosmetic products which are under control of Regional Inspectorates: enterprises (2 times per year), storehouses (1 time per year) and supermarkets/shops (no obligatory requirements), hairdressing and beauty salons and studios (2 times per year) Thematic checks-up (more detailed control/ examination) – 2 for 2008 Thematic checks-up (more detailed control/ examination) – 2 for 2008

18. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD BASIS FOR INSPECTIONS / INSPECTIONS PER YEAR Each of 28 Regional Inspectorates on the basis of MoH’s National instruction (plan) and regional priorities, circumstances and experience elaborate own annual plan, incl. for inspection Each of 28 Regional Inspectorates on the basis of MoH’s National instruction (plan) and regional priorities, circumstances and experience elaborate own annual plan, incl. for inspection Each of 28 Regional Inspectorates maintain Register of Non Food Establishments, incl. “establishments for cosmetic products” which are under their control (enterprises, storehouses, supermarkets/shops, hairdressing and beauty salons and studios, etc.) Each of 28 Regional Inspectorates maintain Register of Non Food Establishments, incl. “establishments for cosmetic products” which are under their control (enterprises, storehouses, supermarkets/shops, hairdressing and beauty salons and studios, etc.) Total number of these establishments and inspections for the whole country (2006): Total number of these establishments and inspections for the whole country (2006): Enterprises – 75 / check-visits 270 Enterprises – 75 / check-visits 270 Storehouses, supermarkets / big shops – 5 054 / check-visits 14 886 Storehouses, supermarkets / big shops – 5 054 / check-visits 14 886 H airdressing and beauty salons and studios – 7 472 / check-visits 21 017 H airdressing and beauty salons and studios – 7 472 / check-visits 21 017

19. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD Main criteria used in the selection of cosmetic products to be tested Annual plan and control priorities for respective year Annual plan and control priorities for respective year Suspicions during the inspection on cosmetic product or marketplace, or enterprise such as: non-compliance or missing information on the label, exceeding period of minimum durability, damaged or improper packaging, improper sale, storage and manufacturing condition, lack of safety file, etc. Suspicions during the inspection on cosmetic product or marketplace, or enterprise such as: non-compliance or missing information on the label, exceeding period of minimum durability, damaged or improper packaging, improper sale, storage and manufacturing condition, lack of safety file, etc. Data from RAPEX notification Data from RAPEX notification Consumer complaints, customs and other organisation requests, etc. Consumer complaints, customs and other organisation requests, etc.

20. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD MAIN NON-COMPLIANCES Labelling Labelling Missing or incorrect information and other non- compliances with the requirements of EU legislation (incl. lack of information on Bulgarian language where appropriate) Missing or incorrect information and other non- compliances with the requirements of EU legislation (incl. lack of information on Bulgarian language where appropriate) Non correct claims on the label which imply that the products have characteristics which they do not have Non correct claims on the label which imply that the products have characteristics which they do not have Ingredients not labelled according to INCI (some imported products with non EU origin) Ingredients not labelled according to INCI (some imported products with non EU origin)

21. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD MAIN NON-COMPLIANCES Safety file Safety file Lack of safety file (some imported products with non EU origin) Lack of safety file (some imported products with non EU origin) Safety file which content not comply with EU requirements Safety file which content not comply with EU requirements Safety of the composition Safety of the composition Microbiological non-conformity Microbiological non-conformity Chemical non-conformity with the requirements of the Annexes II, III, IV, V and VI of the Directive Chemical non-conformity with the requirements of the Annexes II, III, IV, V and VI of the Directive

22. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD FEEDBACK ON INSPECTION Protocol of inspection (check-visit) Protocol of inspection (check-visit) Warrant note with deadline to correct the incompliance (problems with labelling, safety file) Warrant note with deadline to correct the incompliance (problems with labelling, safety file) Restriction or prohibition (temporary or permanent) for placing on the market or withdraw product from the market, incl. recall from the consumers, if appropriate (problems with labelling, safety file, safety of contents) Restriction or prohibition (temporary or permanent) for placing on the market or withdraw product from the market, incl. recall from the consumers, if appropriate (problems with labelling, safety file, safety of contents) Bans and recall of the products from the market, incl. if appropriate recall from the consumers and destruction or use for other purposes (problems with safety of contents) Bans and recall of the products from the market, incl. if appropriate recall from the consumers and destruction or use for other purposes (problems with safety of contents) Penalties according to Law for the Health, if appropriate (problems with labelling, safety file, safety of contents) Penalties according to Law for the Health, if appropriate (problems with labelling, safety file, safety of contents) RAPEX notifications RAPEX notifications

23. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD ANNUAL REPORT Each of 28 Regional Inspectorates prepares annual report for their activities in the field of State Health Control. Part of this report contains data for the control of cosmetic products. Each of 28 Regional Inspectorates prepares annual report for their activities in the field of State Health Control. Part of this report contains data for the control of cosmetic products. On the basis of regional reports and activities on national level MoH prepares National annual report for the State Health Control activities. Part of this report contains relevant data for the cosmetic products. There is no separate report for the cosmetic products. On the basis of regional reports and activities on national level MoH prepares National annual report for the State Health Control activities. Part of this report contains relevant data for the cosmetic products. There is no separate report for the cosmetic products.

24. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD COOPERATION BEETWEEN AUTHORITIES on national level EXAMPLE: RAPEX activities for cosmetic products in Bulgaria (in cases of notification received by the EC) Information from the Consumer Protection Commission (national RAPEX contact point) to the Ministry of Health containing RAPEX notification for the cosmetic products Information from the Consumer Protection Commission (national RAPEX contact point) to the Ministry of Health containing RAPEX notification for the cosmetic products Checking in the MoH’s national register for cosmetic products placed on the market Checking in the MoH’s national register for cosmetic products placed on the market Information to/from the Customs Agency for the products with third country origin Information to/from the Customs Agency for the products with third country origin Order to the Regional Inspectorates to check the product’s presence on the market Order to the Regional Inspectorates to check the product’s presence on the market Summarizing in the MoH the information received and if necessary demand for additional action, incl. laboratory analysis Summarizing in the MoH the information received and if necessary demand for additional action, incl. laboratory analysis Information about the results to the Consumer Protection Commission and if necessary to the Customs Agency and other institutions Information about the results to the Consumer Protection Commission and if necessary to the Customs Agency and other institutions

25. CHALLENGES AND BEST PRACTICE IN TRANSITION PERIOD THANK YOU FOR YOUR ATTENTION