REGULATION (EC) No 1223/2009OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cosmetic products
BACKGROUNDCouncil Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relatingto cosmetic products has been significantly amended on several occasions.Since further amendments are to be made, in this particular case it should be recast as one single text in theinterests of clarity.A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give roomfor diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements areimplemented at the same time throughout the Community.This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrativeburden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics,such as in-market control, with a view to ensuring a high level of protection of human health.This Regulation comprehensively harmonises the rules in the Community in order to achieve an internalmarket for cosmetic products while ensuring a high level of protection of human health.The regulation was signed on 30 November 2009 and it will be completely replaced the current valid ECCosmetic Directive 76/768 and by extension most of the national provisions which are set out in the differentsEU member states.Regulation 1223/2009 will enter into force on 11 July 2013
DEFINITIONSCosmetic Product means any substance or mixture intended to be placed in contact with the external parts ofthe human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and themucous 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 odoursManufacturer means any natural or legal person who manufactures a cosmetic product or has such a productdesigned or manufactured, and markets that cosmetic product under his name or trademarkDistributor means any natural or legal person in the supply chain, other than the manufacturer or theimporter, who makes a cosmetic product available on the Community marketMaking available on the market means any supply of a cosmetic product for distribution, consumption or useon the Community market in the course of a commercial activity, whether in return for payment or free ofchargePlacing on the market means the first making available of a cosmetic product on the Community marketResponsible person Only cosmetic products for which a legal or natural persons designated within theCommunity as ‘responsible person’ shall be placed on the market.For each cosmetic product placed on the market, the responsible person shall ensure compliance with therelevant obligations set out in this Regulation.The distributor shall be the responsible person where he places a cosmetic product on the market under hisname or trademark or modifies a product already placed on the market in such a way that compliance withthe applicable requirements may be affected.
NEW FOCUS ON SAFETY The safety requirements to be metby products have been reformulated in Article 3 of Chapter II. It stipulates that cosmetic prodcuts must be safe when applied under normal or reasonably conditions of use. The requirement that a product must be safe is worded more strictly than in the previous provision which states that a cosmetic product may not cause damage to health.NB data referred to US market only With more than 11 billion personal care products sold each year, and typically only 150 adverse experiences (mostly skin rashes or allergies) reported, cosmetics remain the safest category of products regulated by the FDA (drugs, medical devices, food, cosmetics and tobacco).
EYE ON QUALITY: COSMETIC cGMPThe manufacture of cosmetic products shall comply with good manufacturing practice with a view toensuring the objectives of Article 1Compliance with good manufacturing practice shall be presumed where the manufacture is in accordancewith the relevant harmonised standards, the references of which have been published in the Official Journalof the European Union (i.e. ISO 22716:2007 Cosmetics -- Good Manufacturing Practices (GMP) -- Guidelineson Good Manufacturing Practices).ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products.These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for thepersonnel engaged in the plant, nor do they cover aspects of protection of the environment.The guidelines in ISO 22716:2007 are not applicable to research and development activities and distributionof finished products
PRODUCT INFORMATION FILEWhen a cosmetic product is placed on the market, the responsible person shall keep a product informationfile for it.The product information file shall be kept for a period of ten years following the date on which the last batchof the cosmetic product was placed on the market.The responsible person shall make the product information file readily accessible in electronic or otherformat at his address indicated on the label to the competent authority of the Member State in which the fileis kept.The information contained in the product information file shall be available in a language which can be easilyunderstood by the competent authorities of the Member State.The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products thathave been notified under Directive 76/768/EEC.
PRODUCT INFORMATION FILEThe product information file shall contain the following information and data :
PRODUCT INFORMATION FILEAccording to Article 40 of the Regulation, the P.I.F. requirement (Article 11) will apply on 11 July 2013.However, according to article 39, by way of derogation from the Directive, cosmetic products placed on themarket before 11 July 2013 may already comply with the P.I.F.-related requirements of the Regulation.In this case, such products need not also comply with Article 7a of the Cosmetics Directive.As a consequence, companies can choose whether to update the P.I.F. before 11 July 2013.Even if the cosmetic product was notified under the new Regulation between 11 January 2012 and 10 July2013, the PIF does not have to be compliant with article 11 before 11 July 2013.In any case, for cosmetic products placed on the market from 11 July 2013, the PIF must comply withrequirements of Article 11.
PRODUCT INFORMATION FILEIn summary, on 11 July 2013, the following cases must be considered:
PRODUCT NOTIFICATIONPrior to placing the cosmetic product on the market the responsible person shall submit, by electronicmeans, the following information to the Commission:(a)the category of cosmetic product and its name or names, enabling its specific identification;(b) the name and address of the responsible person where the product information file is made readilyaccessible;(c) the country of origin in the case of import;(d) the Member State in which the cosmetic product is to be placed on the market;(e) the contact details of a physical person to contact in the case of necessity;f) the presence of substances in the form of nanomaterials and:(i) their identification including the chemical name (IUPAC)and other descriptors as specified in point 2 of(ii) the Preamble to Annexes II to VI to this Regulation;(ii) the reasonably foreseeable exposure conditions;(g) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified ascarcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI toRegulation (EC) No 1272/2008;(h) the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.
NANOMATERIALSNanomaterial means an insoluble or bio-persistant and intentionally manufactured material with one ormore external dimensions, or an internal structure, on the scale from 1 to 100 nm.According to the Regulation, a long list of information regarding nano materials shall be send to theCommission in order to give all the assurances from a toxicological point of view.In the event that the Commission has concerns regarding the safety of a nanomaterial, the Commissionshall, without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use in therelevant categories of cosmetic products and on the reasonably foreseeable exposure conditions.The Commission shall make this information public. The SCCS shall deliver its opinion within six months ofthe Commission’s request.Where the SCCS finds that any necessary data is lacking, the Commission shall request the responsibleperson to provide such data within an explicitly stated reasonable time, which shall not be extended.The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of theSCCS shall be made publicly available.LABELLING OF NANOMATERIALSAll ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. Thenames of such ingredients shall be followed by the word ‘nano’ in brackets.
COSMETOVIGILANCEMember States shall monitor compliance with this Regulation via in-market controls of the cosmetic productsmade available on the market.They shall perform appropriate checks of cosmetic products and checks on the economic operators on anadequate scale, through the product information file and, where appropriate, physical and laboratory checkson the basis of adequate samples.Member States shall also monitor compliance with the principles of good manufacturing practices.In the event of serious undesirable effects, the responsible person and distributors shall without delay notifythis to the competent authority of the Member State where the serious undesirable effect occurredWhere the responsible person reports serious undesirable effects to the competent authority of the MemberState where the effect occurred, that competent authority shall immediately transmit the informationreferred to in paragraph 1 to the competent authorities of the other Member States.Where distributors report serious undesirable effects to the competent authority of the Member State wherethe effect occurred, that competent authority shall immediately transmit the information referred to inparagraph 1 to the competent authorities of the other Member States and to the responsible person.Where end users or health professionals report serious undesirable effects to the competent authority of theMember State where the effect occurred, that competent authority shall immediately transmit theinformation on the cosmetic product concerned to the competent authorities of the other Member States andto the responsible person.