Negotiating Group for the Accession of the Republic of Serbia to the European Union - Chapter 28, Consumer and Health Protection COSMETIC PRODUCTS Institute for Public Health of Serbia Dr Milan Jovanović Batut Chapter 28 Consumer and Health Protection Brussels, 3-4 February 2015 1
CONTENTS 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 2
CHAMBER OF COMMERCE AND INDUSTRY OF SERBIA Manufacturing of cosmetics products: 89 3
LEGAL FRAMEWORK Law on Health Safety of Products of General Use (OG RS No 92/11) Art. 3., 4.7 and 4.8 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 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 4
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). 5
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; 6
EU LEGAL FRAMEWORK Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products which is replaced by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products with amendments Regulations (Commission Regulation (EU) No. 658/2013 of 10 July 2013 amending Annex II. and III. Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products; Commission Regulation (EU) No. 655/2013 of 10 July 2013 establishing common criteria for justification of claims that are used in connection with cosmetic products) 7
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 National regulations which will transpose the provisions of this Regulation are currently in the process of development 8
Statutory Requirements for Cosmetics in the Republic of Serbia According to the Law health unsafe cosmetics products are the cosmetic products which might jeopardize health related to their composition or other properties Rulebook specifies health safety requirements for placing cosmetic product on the market ; Cosmetic products must not, in common usage, adversely affect health. 9
LEGAL FRAMEWORK 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 10
LEGAL FRAMEWORK 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). 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. 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. 11
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 It is forbidden to attribute medicinal properties to cosmetic products. It is forbidden to falsely advertise cosmetic products or advertise them in a way that consumers are misled as to the actual composition, properties or purposes of those products. 12
LEGAL FRAMEWORK Maximum allowable amounts of 6 (7) metals, calculated on 1 kg assets Group A (mg ) Group B (mg ) Group C (mg ) As < 5 < 5 < 5 Cd < 1 < 2 < 5 Hg < 3 < 5 < 10 Pb < 10 < 20 < 30 Cr < 50 < 50 < 50 Ni < 50 < 50 < 50 Ba / < 100 / The restrictions listed in the table shall not apply to funds that are after a short time removed from the skin or used for beautification and coloring hair and nails 13
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 14
LEGAL FRAMEWORK This provisions shall not apply to the following products: - Solid soaps; - Hairspray; - Nail polish; - Aerosols that do not include water; - Hair dyes; - Shaving cream; - Depilatories; - Fasteners for hair; - Deodorant in stick form; - Funding for cold perm and neutralizer; - Colognes and perfumes. 15
LEGAL FRAMEWORK 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 16
LEGAL FRAMEWORK The provisions of the applicable Rulebook also stipulate that the cosmetic products designed for personal hygiene, care and beauty of face and body must not contain hormones, antibiotics, pesticides and radioactive substances And determines allowed ph value for different type of cosmetic products. 17
Obligations of Cosmetic Products Economic Operators Tracebility must be ensured in all stages of production and trade of cosmetic products. Cosmetic products operator is obliged to have the documentation to identify business operators who supplies him as well as business operators who are supplied by him with the raw materials, materials, or/and cosmetic products Cosmetic products which are placed on the territory of the Republic of Serbia shall be marked in the prescribed manner for the purpose of identification and traceability. 18
Procedures for health unsafe cosmetic products Cosmetic product economic operator is obliged to stop production or trade of the unsafe cosmetic product, and if such product have changed their owner, the business operator is obliged to inform the cosmetic product holder, the Ministry of Health, and the public. When unsafe cosmetic product have reached the consumers, the economic operator is obliged to, efficiently and clearly inform the consumers on the reasons for recalling the cosmetic product and, if it is necessary, demand from the customers to return the cosmetic product that has already been delivered to them, if there are no other measures for ensuring the high level of health protection 19
Procedures for health unsafe cosmetic products 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. 20
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 21
Administrative Capacity of Ministry of Health SECTOR FOR HEALTH SERVICE ORGANIZATION SECTOR FOR HEALTH INSURANCE SECTOR FOR PUBLIC HEALTH & PROGRAMMED HEALTHCARE SECTOR FOR EUROPEAN INTEGRATION& INTERNATIONAL COOPERATION SECTOR FOR MEDICATIONS AND MEDICAL DEVICES, CONTROLLED PSYCHOACTIVE SUBSTANCES & PRECURSORS SECTOR FOR INSPECTION AFFAIRS Department of Health Care 9 Department of Health Technology and Human Resource Development 9 Department of monitoring and improvement of entitled to compulsory health insurance and voluntary Health insurance 7 Group for Public Health 4 Department of Programmed Healthcare 5 Department for European Integration, Planning and Project preparation 5 Group for the Implementation and Monitoring of IPA Projects and International Cooperation 3 Group for Medications and Medical Devices 3 Department for Controlled Psychoactive Substances & Precusors 8 Department for Sanitary Inspection 161 / 152 Department for Health Inspection 49 Department for Inspections for Medications& Medical Devices 9 22
Administrative Capacity SANITARY INSPECTION 217/208 inspectors* 187/179 sanitary inspectors for TERRITORIAL SURVEILLANCE (122 sanitary inspectors in Central Serbia + 57 in Autonomous Province of Vojvodina) 30/29 sanitary inspectors for the BORDER AREA Department of Coordination and Internal Control (Centar level) 9/8 inspectors 7 Department for sanitary surveillance in Vojvodina 57/57 inspectors Novi Sad (South Backa District) Sremska Mitrovica (Srem District) Subotica (North Backa District) Sombor (West Backa District) Zrenjanin (Central Banat District) Pancevo (South Banat District) Kikinda (North Banat District) 4 Department for Sanitary Surveillance In the border Area 30/29 inspectors Belgrade Šabac Subotica Dimitrovgrad 14 Department for Sanitary Surveillance 121/114 inspectors Sabac (Macva District) Pozarevac (Branicevo & Bor District) Uzice (Zlatibor District) Kraljevo (Raska District) Krusevac (Rasina&Morava River District) Vranje (Pcinj District) Nis (Nis & Toplica District) Valjevo (Kolubara District) Leskovac (Jablanica District) Pirot (Pirot District) Cacak (Moravica District) Belgrade (City of Belgrade) Smederevo (Danube River Basin District) Kragujevac (Sumadija District) 23
Official controls and Market Surveillance 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. 24
Border control 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. Customs authorities cannot conduct customs clearance for import cosmetic products without inspector s decision. 25
Border control Sanitary inspection Administrative control (92 % shipment) Documentation Laboratory inspection (8 % shipment) Sanitary inspection only recognizes findings and opinions of the authorized laboratories. 0,02 % health unsafe shipments Of the total number of laboratory-controlled shipments 0,23% were unsafe Main reasons for unsafety: Microbiological contamination (increased number of aerobic mesophilic bacteria, the presence of yeasts and molds), presence of unauthorized preservatives, increased content of barium... 26
Cosmetic Products Market Surveillance Sanitary inspection internal market surveillance Inspection control according to the Annual working plan, notice of other inspections and complaints of consumers - 2,5 % were health unsafe; inspector banned market and against business operators who have such cosmetic products placed on the market have been filed misdemeanor charges. Monitoring according to the Annual Program based on the proposal of the Institute of Public Health of Serbia, enacted by the Minister of Health, implemented by institutes for public health, financed by the budget of Republic of Serbia (in the period (2011-2014) the necessary funds in the budget were not provided) 27
Rapid Alert System legal basis and procedures Informing consumers about dangerous products / cosmetic products 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) are 28
Authorized Laboratories 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. Only accredited laboratory pursuant to the SRPS ISO 17025 standard for the field of cosmetic product testing could be authorized There is a statutory obligation on information delivery on conducted testing to the Institute of Public Health of Serbia, further delivered to the Ministry of Health-functional only between institutes of public health. 29
Compliance cosmetic products with the Regulation is a fundamental requirement to ensure the safe placing products on the market. However, meeting the demands of others, supporting legislation are required to ensure product safety and health safety, and ultimately consumer protection and freedom of movement of goods on the Serbian and European market. 30
HARMONIZATION According to the National Programme for the Adoption of the Acquis (NPAA) the expected period for developing national regulations for the adoption of the regulation that is currently being drafted is the I quarter of 2015 fully implemented until 2016, fully transposing until 2018. Application for help and support of the PLAC project on drafting legislation that will transpose the requirements of the EU Cosmetic products legislation in order to achieve a high level of protection of the health and safety. Trainings all staff included in cosmetic products control and EU Regulation 1223/2009 implementation TAIEX and other EU projects; Workshops with the aim of familiarizing all interested subjects with the obligations deriving from demands of EU Cosmetic Regulation 1223/2009 Workshops with the aim of familiarizing accredited laboratories involved in the cosmetic products health safety system of control (related to demands of EU Cosmetic Regulation 1223/2009) 31
Negotiating Group for the Accession of the Republic of Serbia to the European Union - Chapter 28, Consumer and Health Protection Thank you for your attention! Institute for Public Health of Serbia Dr Milan Jovanović Batut Brussels, 3-4 February 2015 32