1. CURRENT SITUATION IN SERBIA REGARDING REQUIREMENTS ON PROCEDURE FOR COSMETIC PRODUCTS DRAGANA RADIĆ JOVANOVIĆ INSTITUTE FOR PUBLIC HEALTH “DR MILAN JOVANOVIĆ BATUT“ BELGRADE, FEBRUARY 2016

2.  LEGAL FRAMEWORK  LEGAL FRAMEWORK IN EU AND TRANSPOSING  PRESCRIBED REQUIREMENTS FOR COSMETIC PRODUCTS IN SERBIA  TRANSPOSING AND HARMONIZATION  INSTITUTIONAL FRAMEWORK  ADMINISTRATIVE CAPACITY  FUTURE PLANS AND CHALLENGES

4. DEFINITION  Cosmetic products means any substance, or mixture which come into contact with the external parts of the human body (epidermis, hair, nails, lips and external genital organs) or with teeth and mucous membranes of the oral cavity with a view of cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them and keeping them in good condition (Art. 3. and 4.7) - aligned with 1223/2009, Law on Health Safety of Products of General Use (OG RS No 92/11) – Art. 3., 4.7 and 4.8  Special-purpose cosmetics shall mean products which are not intended to have primarily biocidal effect, which are applied to skin and mucous membranes, or come into contact with other parts of the body (hair, nails, etc.), and unlike other cosmetics, have a special effect, specific purpose and limited time of application – not aligned with 1223/2009

5. LEGAL FRAMEWORK  Law on Health Safety of Products of General Use (OG RS No 92/11)  Rulebook on the conditions in terms of health safety of products for general uses that can be put on the market (OJ SFRY No 26/83, 61/84, 56/86, 50/89, 18/91) – not compliant with the relevant EU legislation

6. LEGAL FRAMEWORK  Rulebook on the conditions in terms of health safety of products for general uses that can be put on the market (OJ SFRY No 26/83, 61/84, 56/86, 50/89, 18/91) – not compliant with the relevant EU legislation.  Law on General Product Safety (OG RS No 41/09) – aligned with the relevant EU regulations;  Law on Market Surveillance (OG RS No 92/11) – aligned with the relevant EU regulations;  Law on Technical Requirements for Products and Conformity Assessment (OG of RS No 36/09) – conformed with the relevant EU regulations;  Law on Chemicals (OG RS No 93/12);  Rulebook on Bans and Restrictions of Production, Placing on the Market, and Use of Chemicals (OG RS No 90/13) - aligned with the relevant EU regulations (REACH).

7. LEGAL FRAMEWORK  Rulebook on Classification, Packaging, Labelling, and Advertising of Certain Chemicals and Products (OG RS No 59/10, 25/11 i 5/12) – our legislation has introduced the DSD/DPD system of classification and labelling;  Rulebook on Classification, Packaging, Labelling, and Advertising of Certain Chemicals and Products in Line with Globally Harmonized Classification and Marking System of the UN (OG RS No 64/10 i 26/11) – our legislation has introduced the CLP/GHS system of classification and labelling

8. LEGAL FRAMEWORK kao i : ISO 10130:2009 ISO 10130:2009 Cosmetics -- Analytical methods -- Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC, post-column photolysis and derivatization ISO 11930:2012 ISO 11930:2012 Cosmetics -- Microbiology -- Evaluation of the antimicrobial protection of a cosmetic product ISO 12787:2011 ISO 12787:2011 Cosmetics -- Analytical methods -- Validation criteria for analytical results using chromatographic techniques ISO/TR 14735:2013 ISO/TR 14735:2013 Cosmetics -- Analytical methods -- Nitrosamines: Technical guidance document for minimizing and determining N-nitrosamines in cosmetics ISO 15819:2014 ISO 15819:2014 Cosmetics -- Analytical methods -- Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS ISO 16212:2008 ISO 16212:2008 Cosmetics -- Microbiology -- Enumeration of yeast and mould ISO/TR 17276:2014 ISO/TR 17276:2014 Cosmetics -- Analytical approach for screening and quantification methods for heavy metals in cosmetics ISO 17516:2014 ISO 17516:2014 Cosmetics -- Microbiology -- Microbiological limits ISO 18415:2007 ISO 18415:2007 Cosmetics -- Microbiology -- Detection of specified and non-specified microorganisms ISO 18416:2007 ISO 18416:2007 Cosmetics -- Microbiology -- Detection of Candida albicans

9. LEGAL FRAMEWORK ISO 21148:2005 ISO 21148:2005 Cosmetics -- Microbiology -- General instructions for microbiological examination ISO 21148:2005/Cor 1:2006 ISO 21149:2006 ISO 21149:2006 Cosmetics -- Microbiology -- Enumeration and detection of aerobic mesophilic bacteria ISO 21150:2006 ISO 21150:2006 Cosmetics -- Microbiology -- Detection of Escherichia coli ISO 22715:2006 ISO 22715:2006 Cosmetics -- Packaging and labelling ISO 22716:2007 ISO 22716:2007 Cosmetics -- Good Manufacturing Practices (GMP) -- Guidelines on Good Manufacturing Practices ISO 22717:2006 ISO 22717:2006 Cosmetics -- Microbiology -- Detection of Pseudomonas aeruginosa ISO 22718:2006 ISO 22718:2006 Cosmetics -- Microbiology -- Detection of Staphylococcus aureus ISO 24442:2011 ISO 24442:2011 Cosmetics -- Sun protection test methods -- In vivo determination of sunscreen UVA protection

10. LEGAL FRAMEWORK ISO 24443:2012 ISO 24443:2012 Determination of sunscreen UVA photoprotection in vitro ISO 24444:2010 ISO 24444:2010 Cosmetics -- Sun protection test methods -- In vivo determination of the sun protection factor (SPF) ISO/TR 24475:2010 ISO/TR 24475:2010 Cosmetics -- Good Manufacturing Practices -- General training document ISO/TR 26369:2009 ISO/TR 26369:2009 Cosmetics -- Sun protection test methods -- Review and evaluation of methods to assess the photoprotection of sun protection products ISO 29621:2010 ISO 29621:2010 Cosmetics -- Microbiology -- Guidelines for the risk assessment and identification of microbiologically low-risk products

11. LEGAL FRAMEWORK CEN ISO/TR 24475:2013CEN ISO/TR 24475:2013 (WI=00392022) Cosmetics - Good Manufacturing Practices - General training document (ISO/TR 24475:2010) CEN ISO/TR 26369:2009CEN ISO/TR 26369:2009 (WI=00392008) Cosmetics - Sun protection test methods - Review and evaluation of methods to assess the photoprotection of sun protection products (ISO/TR 26369:2009) EN 16342:2013EN 16342:2013 (WI=00392015) Cosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic anti- dandruff products EN 16343:2013EN 16343:2013 (WI=00392016) Cosmetics - Analysis of cosmetic products - Determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic preparations, LC-MS methods EN 16344:2013EN 16344:2013 (WI=00392017) Cosmetics - Analysis of cosmetic products - Screening for UV-filters in cosmetic products and quantitative determination of 10 UV-filters by HPLC.

12. LEGAL FRAMEWORK EN 16521:2014EN 16521:2014 (WI=00392020) Cosmetics - Analytical methods - GC/MS method for the identification and assay of 12 phthalates in cosmetic samples ready for analytical injection EN ISO 11930:2012EN ISO 11930:2012 (WI=00392013) Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2012, Corrected version 2013-05-01) EN ISO 16212:2011EN ISO 16212:2011 (WI=00392019) Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2008) EN ISO 17516:2014EN ISO 17516:2014 (WI=00392021) Cosmetics - Microbiology - Microbiological limits (ISO 17516:2014) EN ISO 18415:2011EN ISO 18415:2011 (WI=00392018) Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2007) EN ISO 18416:2009EN ISO 18416:2009 (WI=00392001) Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2007)

13. LEGAL FRAMEWORK EN ISO 21148:2009EN ISO 21148:2009 (WI=00392002) Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005) EN ISO 21149:2009EN ISO 21149:2009 (WI=00392003) Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2006) EN ISO 21150:2009EN ISO 21150:2009 (WI=00392004) Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2006) EN ISO 22716:2007EN ISO 22716:2007 (WI=00392005) Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (ISO 22716:2007, Corrected version 2008-05-15) EN ISO 22717:2009EN ISO 22717:2009 (WI=00392006) Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2006) EN ISO 22718:2009EN ISO 22718:2009 (WI=00392007) Cosmetics - Microbiology - Detection of Staphylococcus aureus (ISO 22718:2006)

14. LEGAL FRAMEWORK EN ISO 24442:2011EN ISO 24442:2011 (WI=00392009) Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011) EN ISO 24443:2012EN ISO 24443:2012 (WI=00392010) Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012) EN ISO 24444:2010EN ISO 24444:2010 (WI=00392011) Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2010) EN ISO 29621:2011EN ISO 29621:2011 (WI=00392014) Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010)

15.  regulates the requirements in regard to the health and safety of consumer products intended for human consumption, manufactured in the Republic of Serbia, or imported or exported for distribution, the conditions for the market survellence, as well as obligations and the responsibilities of the operators  it is allowed to place on the market only health safe consumer products  The Minister responsible for health shall prescribe the conditions regarding the health and safety of consumer products Law on Health Safety of Products of General Use (OG RS No 92/11)

16. Health improper cosmetic products are those : 1)who dont have the declaration, or if the composition does not match the declared if they are out of date indicated on the label, or if there is no information on the period of use prescribed for this type of product 2)if their sensory properties are changed due to physical, chemical, microbiological or other processes ; 3)if their form, method of preparation and / or processing while using, presents a risk to human health ; 4)if they contains substances or ingredients that are not allowed, or they are present in the prohibited quantity, which may adversely affect human health 5)if it contains microorganisms in quantities larger than permitted, or other micro- organisms harmful to human health;

17. 6) if in contact with food or other consumer products contains or releases substances that can adversely affect human health or substance that can change the sensory properties of food and consumer products 7) if they contains radionuclides above the limits set by special regulations 8) if they are contaminated by physical additions that may be harmful to human health or cause disgust. For consumer products which come into direct contact with skin or mucous membranes, objects to decorate the face and body piercing and imitation of jewelry, substances or components referred to in paragraph 1, item 4) of this Article, are determined by the regulation governing the restrictions and prohibitions production, the marketing and use of chemicals.

18.  it is forbidden to attribute medicinal properties to cosmetic products  consumer products falsely advertise or advertise in a way that consumers are misled as to the actual composition, characteristics or purposes are prohibited,  consumer products advertising are regulated upon Law which regulates the conditions and manner of advertising

19.  Law on health safety of consumer products defines the obligations and responsibilities of operators (in this case, cosmetic products)  Traceability have to be ensured in all stages of production and trade of cosmetic products  Business operator shall have documentation which identifies how entities of which procures raw materials, materials and consumer products, as well as entities that supply raw materials, materials and finished products, and shall ensure the availability of data on traceability competent authorities for performing official control.  Cosmetic products placed on the market on the territory of the Republic of Serbia shall be marked in the prescribed manner for identification and traceability.

20.  If these products have changed owners, operators are obliged to inform the ministry responsible for public health and the public.  In those cases where the health unsafe cosmetic products, reach consumers, business operators shall, in an efficient and transparent way inform consumers on the reason for the recall of these products and, if necessary, require the consumer return of products which had already been delivered, if other measures can not achieve a high level of health protection

21.  Based on the written notice of the Ministry of Health or inspector that there is a reasonable doubt in health safety of the cosmetic product, the economic operator is obliged to temporary withdraw the cosmetic product until the health safety certificate is provided, and a written notice is delivered to the Ministry of health  If cosmetic product, for which there is a reasonable doubt in the health safety, has changed the owner, the economic operator is obliged to recall the cosmetic product from the holders and to inform the Ministry of health and public.

22.  Rulebook, specifies health safety requirements for placing cosmetic product on the market  Cosmetic products must not, in common usage, adversely affect health.

23.  Conditions related to health safety of cosmetic product are precisely defined in the Rulebook on the conditions in terms of health safety of products for general uses that can be put on the market (OJ SFRY No 26/83, 61/84, 56/86, 50/89, 18/91) – articles from 101 till 115 and and accompaning lists (I - IV) which are not aligned with the relevant EU legislation LEGAL FRAMEWORK

24. Cosmetic products are divided into three categories :  Items coming into contact with mucous membranes (group A);  Items that remain on the skin for a long time (group B)  Items that after a short time are removed from the skin or are used for the treatment and dyeing of hair or nails (group C)

25.  Cosmetic products may be marketed only in the original wrapping of manufacturers, in a packaging that enables proper use and protects the hygienic quality of individual products. LEGAL FRAMEWORK

26.  Cosmetic products must contain declaration, if their effect depends on the proper application and instructions for use, and for some products also the way and manner of use and the test on sensitivity.

27. LEGAL FRAMEWORK  Cosmetic products designed for personal hygiene, care and beauty of face and body that contain ingredients whose effect is especially emphasized in the original packaging must contain a generic name and the amount of these ingredients expressed as a percentage or units of measurement (in international units for biologically active substances).  The aerosol packages amounts of the components refers to the total of the dose

28. LEGAL FRAMEWORK  Cosmetic products designed for personal hygiene, care and beauty of face and body are not allowed to containe (estimated to 0.1 g or 0.1 ml of cosmetic product ) : 1) coagulase-positive staphylococci; 2) Pseudomonas aeruginosa; 3) Escherichia coli; 4) Proteus species.  Number of aerobic mesophilic bacteria in 1 g or 1 ml must not be greater than 1000.  The number of yeast and mold spores in 1 g or 1 ml of funds for personal hygiene, care and beauty of face and body must not be higher out of 100

29. LEGAL FRAMEWORK

30. Ingredients with specific attention are shown in the Lists I-IV, which are an integral part of the applicable Rulebook  List I preservatives  List II antioxidant agents  List III colorants  List IV cosmetic active substances, vitammines and other similar substances, UV filters not compliant with the relevant EU legislation

31. LEGAL FRAMEWORK The Rulebook stipulates that cosmetic products intended for personal hygiene, care and beauty of face and body should not contain hormones, antibiotics, pesticides and radioactive substances A precise and pH values for different types of products

32.  The products for personal hygiene, care and beauty of face and body must have the following pH value: 1)for those that only come into contact with the mucous membrane, - from 4.0 to 9.0, with the exception of toothpastes based on calcium carbonate and soap, which can have a pH value of up to 10.0 2)products which after a short time have been removed from the skin or hair - from 3.0 to 12.0, with the exception depilatories, which can have a pH value to 12.5; 3)products that stay longer on hair and nails can have a pH value of 3.5 to 8.5; 4)Products for neutralization above mentioned products ( 2.1) can have pH value from 2,5-12,5.  Coloring agents and beautification for face and eyes, milk and cleansing creams and powders for the face, body and legs can have a pH value of 3.5 to 9.0; deodorants, antiperspirants and other products based on soap - from 3.5 to 9.5 and the other assets that remain on the skin for longer - 3.5 to 8.0.  For products that do not contain water, or which contain organic solvents and after use create a film on the hair or nails (hair sprays, nail polish, etc.) pH value is not determined.

33. Transposition of the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products is an obligation from the Stabilization and Association Agreement between Serbia and the EU Free movement of cosmetic products on the EU internal market, is only permitted if the cosmetic products meet the requirements of compliance with the requirements defined in the Regulation on cosmetic products

34. INSTITUTIONAL FRAMEWORK The Ministry of Health is authorized :  to transpose Regulation EU 1223/2009 into national legislation  for implementation (through sanitary inspectors – internal surveillance and border surveillance)  Authorized accredited laboratories for health safety assessment – laboratory testing  Accreditation Body of Serbia – accreditation of laboratory according to the SRPS ISO17025 standard  The Ministry of Trade, Tourism and Telecommunications and The Ministry of Economy (information exchange on the unsafe products, technical regulations registration and notified of conformity assessment bodies)  Institute for Standardization– adopting technical standards

37. Official controls and market surveillance include: Official controls are carried out as:  production control in all phases,  trade control in all phases,  health safety control of cosmetic products,  control of internal control procedures,  inspection control (sampling for laboratory testing) – when health safety is questioned or when there is no other possibility for checking health safety,  monitoring program.

38.  Before customs clearance, Importer is obliged to submit to the sanitary inspector at the place of customs clearance a written request and documentation of relevance for determining health safety.  Inspector approves by his written decision import of health safe cosmetic products, or bans import of health unsafe cosmetic products, within three days from the official control enforcement.

39. Customs authorities cannot conduct customs clearance for import cosmetic products without inspector’s decision

40. SANITARY CONTROL FOR IMPORTED PRODUCTS I ncludes: control of documents, inspection of the conditions for transport and storage, physical examination of the products - organoleptic inspection and verification of the declaration, products sampling neccesary for laboratory testing health safety.

41. SANITARY CONTROL FOR IMPORTED PRODUCTS  Sanitary inspection Administrative control (92 % shipment) Documentation Laboratory inspection (8 % shipment) Sanitary inspection only recognizes findings and opinions of the authorized laboratories.

42. SANITARY CONTROL FOR IMPORTED PRODUCTS in accordance with the procedures for import every product, first imported, for placing on the market of RS, shall be inspected This includes : document review, examination of the conditions for transport and storage, and laboratory checks in authorized laboratories.

43.  Only authorized laboratories (which meet the requirements of accreditation, facilities, equipment and qualified personnel) can be engaged for the laboratory testing on health safety of cosmetic products in the official controls.  Authorization is given by the Minister of health. Every decision on authorization is issued in „Official Gazette of RS“. 0.02% of total shipments in 2014 health unsafe From the total number of laboratory-controlled consumer products - 0.23% were health unsafe

44. The leading causes of problem:  microbiological contamination (increased number of aerobic mesophilic bacteria, the presence of yeasts and molds)  the presence of unauthorized preservatives  increased content of barium etc..

45. MARKET SURVEILLANCE Market surveillance over cosmetic products is the responsibility of the Sanitary Inspection of the Ministry of Health and includes:  Inspection control determined by annual plans for monitoring and  monitoring realization program determined by Institute for Public Health of Serbia proposal Intended method of financing the program of monitoring the budget of the Republic of Serbia. Due to lack of funds in the period 2011-2014. the necessary funds were not provided, and accordingly has not provided a monitoring plan implemented

46. Informing consumers about dangerous products / cosmetic products in RS is regulated by:  Law on General Product Safety (OG RS No 41/09);  Rulebook on establishing and operating the rapid alert system for dangerous products (OG RS No 89/09);  Rulebook on Content and Manner of Notifications on Dangerous Products (OG RS No 112/09).  Contact point for informing consumers related to dangerous products and contact for rapid information exchange is at the Ministry of Trade, Tourism and Telecommunications  A contact point is designated at the Ministry of Health which is responsible for providing information to the contact point at the Ministry of Trade, Tourism and Telecommunications on dangerous cosmetic products (http://www.nepro.gov.rs/default.aspx)http://www.nepro.gov.rs/default.aspx

48. Main processsies EUSerbia Classification exists not exist RP nomination exists not exist PIF exists not exist Portal Notification exists not exist

51. According to the National Programme for the Adoption of the Acquis (NPAA) the expected period for fully harmonization, transposing and implementation is December 2018. National institutions involved in this process, led by the Ministry of Health, in the field of cosmetic products, in the previous period have undertaken a series of activities that included the following:  drafting legislation working groups formation  applying for projects related to assistance and support in the process of transposing EU legislation and necessary for the proper implementation guide training of employees involved in the process of transposing, harmonization and implementation of regulations  training cosmetic products business operators amending regulations and requirements placed upon them through workshops and round tables etc.

52. Current activities include:  currently available capacity assessment and planning  drafting new legislation  strengthening administrative capacity and institutions working on the tasks entrusted in this sector

53. Thank you for your attention dragana_radic@batut.org.rs Dragana Radić Jovanović Institute for Public Health of Serbia “Dr Milan Jovanović Batut“