Market Surveillance -Inspection and controls, In-market control Dr. Simona Pârvu Ministry of Health Romania Belgrad, of February 2016 TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products

Cosmetics Regulation CHAPTER VII - MARKET SURVEILLANCE In-market control Article 22 Communication of serious undesirable effects Article 23 Information on substances Article 24 CHAPTER VIII - NON-COMPLIANCE, SAFEGUARD CLAUSE Non-compliance by the responsible person Article 25 Non-compliance by distributors Article 26 Good administrative practices Article 28

Regulation 765/2008 Sets out the framework for monitoring products in the European market to guarantee that they meet requirements, thus ensuring a high level of protection of public interests.

Regulation 765/2008 Art. 18 MS shall establish, implement and periodically update their market surveillance programmes. communicate those programmes to the other MS and the Commission available to the public

National market surveillance programmes National market surveillance programmes for 2016: Sector specific activities (supervision, inspection and control on the market of biocidal products, cosmetics products and tobacco products) planned by Romania Sectors Applicable EU legisl ation StateProduct categories and objective of project Starting period and duration Person of contact within the authority (name, and telephone number) 02. Cosmetics Regulation (EC) 1223/ 2009 RO In-market surveillance for checking the producers on verifying compliance with good manufacturing practice - Ministry of Health 2 nd quarter 2016 Ministry of Health, State Sanitary Inspection 02. Cosmetics Regulation (EC) 1223/ 2009 RO In-market surveillance for checking the producers, importers, distributors, retail units, beauty salons for cosmetic products which contains: izopropilparaben, izobutilparaben, fenilparaben, benzilparaben and pentilparaben - Ministry of Health 3rd quarter 2016 Ministry of Health, State Sanitary Inspection - Inspection of prohibited ingredients in cosmetics (notification, label) - Product testing (parabens) on creams and lotions (face, body, feet etc.) for children, adults

Regulations requires the national governments of EU Member States to have surveillance systems that monitor compliance with all requirements. an official body in each country carries out in-market control inspections.official body in each country mandatory product information such as manufacturer’s details, product content, durability, precautions for use and ingredients must be accessible to the inspecting body.

National legislation Goverment Decision nr. 147/2015 establishes that de Ministry of Health (MoH) is the competent authority in Romania for cosmetics products. Other authorities with responsibilities for cosmetic products are: National Authority for Consumer Protection Customs. The role of the MoH as the competent authority for cosmetic products is to ensure that all cosmetic products on the Romanian market meet the requirements of the cosmetic product legislation and in doing so, do not compromise the health and safety of the consumer and any other persons where appropriate.

AUTHORITIES

In-market surveillance The competent market surveillance authorities monitor and control products on the market and change of information between authorities. They are responsible for: monitoring compliance with product safety requirements; monitoring accidents and damage to health suspected to have been caused by these products; following up and updating scientific and technical knowledge concerning safety issues; following up on the notification of dangerous products on RAPEX.

In-market surveillance Market surveillance authorities must perform appropriate checks on the characteristics of products through: documentary, physical and laboratory checks these bodies have powers to analyse samples for compliance with requirements for labelling, ingredients and microbiological quality. testing must be carried out in accordance with official European methods in accredited laboratories.

In-market surveillance Cooperation and exchange of information through Platform of European Market Surveillance Authorities for Cosmetics (PEMSAC)

In-market control Inspectors can carry out product controls for different reasons: Planned or Random controls Thematic Controls Verifying corrective action has been taken; Controls on a product following a recurrent complaint Controls for products notified trough RAPEX and SUE Controls for product compliance following new regulation, use of a newly regulated substance, or to assess labelling of new warnings

Planned or random controls checks of cosmetic products and on the economic operators (producer, importer, distributors, retailers) for general compliance of cosmetic products (labelling, composition, claims etc) Category of product New products New producer physical and laboratory checks

Thematic Controls on specific cosmetic product categories or ingredients or other specific parts of PIF sunscreen products, cosmetic products for babies, etc. ingredients (hydroquinone, formaldehyde,... ) PIF (safety assessment for children in universal products, nanomaterials, etc.) GMP In conformity the National market surveillance program

RAPEX was created trough Directive 2001/95/EC for General product safety Article 12 Article 11 Annex II RAPEX Guidelines (2004/418/EC) – procedure manual which establishes how to operate in RAPEX sistem

RAPEX 1. Non-food products 2. Serious risk to the consumers safety and health 3. Corrective measures taken by the authorities or voluntary by the economic operator 4. Transfrontier efect. Informs the European country in which the PIF is made available and the Commission

SUE Notification Requirement Who? Responsible person, Distributor, Competent Authorities Where ? Country where serious undesirable effect occurred When ? Without delay How ? Harmonised report forms

What do inspectors control? the good manufacturing practice the safety assessment the requirements for the product information file the provisions on sampling and analysis the notification the restrictions for substances the animal testing requirements the labelling requirements Verifying corrective action has been taken!

Measures Measure must be proportionate to the risk. If the authorities identify a product as presenting a risk, inspectors take the appropriate measures: Warning Fee the product is recalled or withdrawn form the market; ban or restrict the making available on the market of the cosmetic product or to produce it. Voluntary measures can be taken and communicated by the economic operator to the authorities

Inspection procedure I 1. Before inspection : systematic previous information about report on checks before, non-complainces and request to prepare or to send list of products, of ingredients, etc. Checks ingrients (Cosmetic ingredient database Cos Ing) exceptionally, unannounced inspection ( complaint, new regulations, etc.)

Cos Ing

Inspection procedure II 2. On the spot, during the inspection: 1 to 3 days 4 phases (generally): 1° opening meeting: to make acquaintances with the different persons and specially qualified persons 2° visit of premises : quick assessment of the site, choice of the differents products whose files will be studied 3° study of files, labellings, documentation, sub contracting documents, GMP 4° closing meeting: to summarize the major points and to make clear what has to be done. Recieving the report.

Inspection procedure III 3. After inspection : the final report concluding the observations, non- compliances, recommendations the economic operator can contest, within 15 days, the conclusions and the measures taken

Inspection check list I informations about the company (turnover, trade marks, different activities) notification file (qualified persons) the most important product, the newest product, a sunscreen product or for babies labellings ingredients GMP

Inspection check list II Advantages during inspection reduces personal factor of the different inspectors assures a fair inspection for anybody helps to write down notes quickly after inspection make easily visible non-compliances, and observations make easier to writte the report (reference texts) is kept in the file as raw data (for later checking)

Product Information Files : non-compliances Lack of file at the address mentionned on the labelling (sometimes, lack of file at any address) Very often, incomplete file: lack of method and results for determining durability and PAO lack of physico-chemical and microbiological specifications of raw materials and finished product lack of method of manufacture insufficient assessment of the safety for human health of the finished product or lack of conclusion or assesment for a different formula lack of proof of the effect claimed for the cosmetic product (sunscreen products) lack of heading to collect existing data on undesirable effects lack of quantitative composition of the product (imported products) or not updated old formula file written in foreign language

Labellings: non-compliances Inconsistancy of the address mentionned on the labelling and the place where the files are held Inconsistancy of the list of ingredients on the labelling and the list of ingredient in the file Durability and/or PAO not corresponding to results for determining them lack of batch number or different batch numbers on the container and on the packaging abbreviation not allowing to identify the responsible for placing on the market lack of mention of allergens

Thank you for your attention!