C onsumer Information Labelling Access to information for the public C onsumer Information Labelling Access to information for the public Dr. Simona Pârvu Ministry of Health Romania TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products Belgrad, of February 2016

Cosmetics Regulation CHAPTER VI - CONSUMER INFORMATION A. Labelling – Article 19 Following information must be given on the packaging or labelling in indelible, easily legible and visible lettering All of the other information must be in the national language and can be supplemented by other languages.

1. NAME AND ADDRESS The name and address of the responsible person established within a member state must be on the container and the packaging. Where the product is manufactured outside the European Economic Area (EEA), the country of origin must also be given. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted  (ex. can be an abbreviation of a city, district, county or country, post cod

2. NOMINAL CONTENT at the time of packaging given by weight or by volume, except in the case of packaging containing:  less than five grams or five milliliters,  free samples and single-application packs for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually (ex. promotional packaging)

3. DURABILITY (1) Where a cosmetic product has a minimum durability of 30 months or less, it must be marked on the container and the packaging with a 'best before' date or the symbol shown. The indication must be in the form 'best used before the end of', followed by the date (day / month / year, or month / year) or an indication of where the date appears on the packaging. If any particular conditions must be observed to guarantee the stated durability, these must also be described.

3. DURABILITY (2) Where a product has a shelf life of more than 30 months, it must be marked with the symbol shown below together with an indication (in months, or years and months, ex. 12 M) of the period after opening for which the product can be used without harming the consumer.

4. PRECAUTIONS Precautions to be observed in use, as shown in the annexes to the Regulation, must be printed on the label. Special precautionary information on cosmetic products for professional use, particularly in hairdressing, must appear on the container and packaging. Ex. “Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy. Do not colour your hair if: - you have a rash on your face or sensitive, irritated and damaged scalp, - you have ever experienced any reaction after colouring your hair, - you have experienced a reaction to a temporary “black henna” tattoo in the past.”

5. BATCH CODE The batch number of manufacture or the reference for identifying the goods.

6. FUNCTION If not otherwise obvious from design and packaging Ex. Lipstick or soap: it is obvious Spray: function must be mentioned - fixing hair or deodorant

7. INGREDIENTS (1) The package in which the cosmetic product is supplied must bear a list of ingredients, headed 'Ingredients' in descending order of weight, determined at the time the ingredient was added to the product. Ingredients in concentrations of less than 1% may be listed in any order after those of 1% or more.

7. INGREDIENTS (2) Perfume and aromatic compositions and their raw materials must be referred to as 'perfume' or 'aroma' unless a more specific indication of their presence is required in Annex 3. Colouring agents may be listed in any order after the other ingredients. For decorative cosmetics marketed in various colours, all colouring agents in the range may be listed so long as the words 'may contain' or the symbol '+/-‘.

7. INGREDIENTS (3) The ingredient name must be that listed in the International Nomenclature of Cosmetic Ingredients (INCI) or If no such name is listed, one of the following:  chemical name  European Pharmacopoeia name  International Non-proprietary Name (INN), as recommended by the World Health Organisation  European Inventory of Existing Commercial chemical Substances (EINECS), International Union of Pure and Applied Chemistry (IUPAC), or Chemical Abstracts Service (CAS) identification reference  colour index number sing/ sing/

7. INGREDIENTS (4) You do not need to include any of the following as ingredients:  impurities in the raw materials  materials used in the preparation of, but not present in, the final product  materials used as solvents or carriers for perfumes and aromatic compositions

7. INGREDIENTS (5) All cosmetic products marketed in any part of the EU have to be labelled with a list of their ingredients, irrespective of the channel of distribution. This requirement also applies to  imported products,  professional products,  free samples,  tester samples,  multi-component products,  products sold by mail order or via the internet,  products provided in hotels and other public facilities.

8. Nanomaterials Definition Art. 2 (k): “Nanomaterial" means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word 'nano' in brackets.  e.g. "titanium dioxide (nano)".

9. Additional information Additional information must be given where certain ingredients, such as preservatives and UV filters, are present. This information is specified in Annexes 3, 4, 5, and 6 to the Regulation.

10. PRESENTATION (1) Rules for ingredients lists must appear on the packaging if it is impossible to do so or there is no packaging, on the container if the product is sold loose, the ingredients list can be given on the container in which the product is exposed for supply or on a notice if this is not possible, the list can be given on a leaflet, label, tag, tape or card enclosed with or attached to the product, along with an indication referring the consumer to it (either by way of abbreviated information or the 'hand and book' symbol). For small products such as soap and bath balls, a notice can be used instead of a leaflet, label, etc.

10. PRESENTATION (2) Rules for OTHER INFORMATION must normally appear on both the container and the packaging if it is not possible for the batch code to appear on the container, it can appear on the packaging only similarly, where there are practical constraints, the conditions for use may appear on a leaflet, label, tag, tape or card enclosed with or attached to the product, again with an indication referring the consumer to it in the case of loose cosmetic products other than soap, all of the information must be given on the container in which the product is exposed for supply, or on a notice in immediate proximity to the container.

B. Claims-Article 20 Misleading Advertisement :... text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have. Commission Regulation (EU) No 655/2013

C. Access to information for the public - Article 21 Information to be made publicly available ( Product identification (product name and company name)  Qualitative and quantitative composition of the product: Qualitative: INCI list Quantitative: only for substances classified as dangerous under Regulation 1272/2008, may be expressed as « <x% » or « x-y% » Perfume and aromatic compositions: name & code number, identity of supplier.  Data on undesirable effects and serious undesirable effects that are very likely or likely to be attributable to the use of the product.

Thank you for your attention !