REGULATION (EC) Nº 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products 1 Shall apply from 11 July 2013

Reasons Current European cosmetic regulations (Directive 76/768/EC) has been amended many times, creating discrepancies in the various countries (to be effective, countries had to transpose into its national legislation). So, the European Authorities thought about a Regulation, that is a legal instrument that shall be binding in its entirety and directly applicable in all Member States. 2

Objective  Simplifying procedures and streamlining terminology. * Reducing administrative burden and ambiguities. * Ensuring a high level protection of human health.  Also: It comprehensively harmonises EU rules  Applies only to cosmetics; not Medicines, not Medical Devices, not Biocides. 3

To determine whether a product is cosmetic or not, based on the definition concerning: Indications for the application site Purpose of use Ingredients 4

Essential Requirements -I- Cosmetic products should be safe under conditions of normal use or reasonably foreseeable. “A positive balance between risk / benefit should not be justification for taking a risk” 5

Essential Requirements -II- The presentation of a cosmetic (shape, smell, size, volume), should not mislead the consumer to understand that it could be food. 6

Essential Requirements -III- To establish the responsibility for each product, there must be a responsible person (company) in the EU. Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. This responsible person is responsible for the safety of a cosmetic and must appear on the labelling. 7

Essential Requirements -IV- Warranty of traceability throughout the supply chain (including the dealer). 8

Essential Requirements -V- To ensure its safety, Cosmetics entering the market must be produced under good manufacturing practices. 9

Essential Requirements -VI- In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification. All products placed on the market must have been previously notified (single for all EC, centrally, electronically, already available) 10

Essential Requirements -VII- The safety of a cosmetic placed in European market can not be based on animal tests. Safety must be based on alternative tests (In vitro, in humans) 12

For the purposes of this Regulation: ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours; Art. 2 -Definitions 13

Art. 2 –Definitions ‘undesirable effect’ means an adverse reaction for humanhealth attributable to the normal or reasonably foreseeableuse of a cosmetic product; ‘serious undesirable effect’ means an undesirable effect whichresults in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death; 14

SAFETY A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following : Presentation Labelling Instructions for use and disposal Any other indication or information relevant provided by the responsible person 15

ANNEX I – COSM. PRODUCT SAFETY REPORT PART A - COSMETIC PRODUCT SAFETY INFORMATION  Quantitative and qualitative composition  Physical / Chemical Characteristics and stability  Microbiological quality  Impurities, traces, information about packaging  Normal and reasonably foreseeable use  Exposure to the cosmetic product and to substances  Toxicological profile of substances  Undesirable effects and serious undesirable effects  Information on cosmetic product 16

PART B - COSMETIC PRODUCT SAFETY ASSESSMENT  Assessment conclusion  Labelled warnings and instructions for use  Reasoning  Assessor’s credentials and approval of part B. 17 ANNEX I – COSM. PRODUCT SAFETY REPORT

Manufacturers and Importers located in Spain must have an Activity Authorization granted by Spanish Health Administration. The Authorization requires adequate installations, implementing a Quality System, a person acting as Technical Director, and a laboratory (own or subcontracted) for the physical-chemical and microbiological analysis. The language of the label must be in Spanish (except name and list of ingredients) 18 SPANISH LEGISLATION (RD 1599/1997)

Importation of cosmetics into Spain can be done by: 1.Spanish importer with its own authorization 2.Subcontract another Spanish company with an import authorization 3.Import the products through another EU country. Once the products are communitary, they can travel freely among all CE countries, including Spain (without passing through spanish customs). 19 SPANISH LEGISLATION (RD 1599/1997)

Gabinete Técnico Farmacéutico M. Camps, SL. We are a pharmaceutical and healthcare consultancy with extensive experience, specialized in advice of technical and legal procedures for the health sector: Cosmetics, Medical Devices, Pharmaceutical Industry, Biocides, Food Industry, Orthopedics, Dental Laboratories, and general health facilities. We carry out the necessary steps for the implementation of relevant regulations in each case, in relation to companies, and to products placed on the national and international market. (SPAIN)