Update of the inventory of ingredients employed …

1 1 SCCNFP/0389/00 FinalTHE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTSINTENDED FOR CONSUMERSOPINIONCONCERNINGTHE 1ST Update OF THE inventory OF INGREDIENTSEMPLOYED IN COSMETIC PRODUCTSSECTION II:PERFUME AND AROMATIC RAW MATERIALSA dopted by the SCCNFP during the plenary sessionof 24 October 200021-PreambleArticle 5a of the Cosmetics Directive 76/768/EEC stipulates that the Commission shallcompile an inventory of ingredients employed in cosmetic products ..shall publish theinventory and shall Update it periodically . Accordingly Commission Decision 96/335/EECof 8 May 1996 established the inventory and a common nomenclature of ingredientsemployed in cosmetic the Cosmetics Directive specifies in the same Article 5a that the inventory iscompiled on the basis in particular of information supplied by the industry concerned ,and in its Article 8 that the SCCNFP must be consulted prior to any amendments to thecurrent task of the SCCNFP was elucidated by a mandate issued by the responsible service of theEuropean Commission (SCCNFP/1891/98) which indicates that the SCCNFP shall act as aresource of scientific expertise to the European Commission, in terms of advising on the:1.

2 Medical and professional expectations and requirements of the Scientific accuracy and validity of proposed Outstanding needs of the existing text/proposed improvements in subsequent order to fulfil its work, scientifically based, the SCCNFP met experts from EuropeanIndustry and worked in collaboration with the JRC (Joint Research Centre) of SCCNFP wishes to acknowledge in particular the co-operation of EFFA (EuropeanFlavour and Fragrance Association) and its scientific experts in establishing the 1st Update ofSection II of the present document includes the opinion of the SCCNFP on the 1st Update of the Inventoryof ingredients employed in cosmetic products (Section II) and, in Annex, the Introduction tothe Update and the Update of the inventory (Section II) as adopted by the paper on Section II of the InventoryThe Commission Decision 96/335/EC establishing the inventory specified that fragranceingredients do not need a common nomenclature because the fragrance or their ingredients (perfume and aromatic compositions and their raw materials) must be indicated on the labelsusing the words perfume or flavour (Article 6 (1) (g) of the Cosmetics Directive).

3 HenceSection II consisted of a list of ingredients defined by their chemical names, EINECS(European inventory of Existing Commercial Chemical Substances) numbers and CAS(Chemical Abstract Service) Registry 1996, the members of the SCC/SCCNFP constantly expressed the opinion that thepublished form of the fragrance inventory was inadequate to serve its role posed by the 6thAmendment to the Cosmetics Directive because the numerical order makes scrutiny of thelisting extremely difficult. It had been suggested that the listing should be changed to analphabetical order, and that when a substance has an INCI name or is more commonly knownby a common name or abbreviation, these names should be included in the inventory Section II, either as principal names in the list, or by reference through a cross reference list.

4 Ithad also been suggested that other additional information should be included, such as main3constituents of ingredients of natural (plant or animal) origin, as well as information on themain fragrance ingredients by tonnage document SCCNFP/0022/98 revising the Section II of the inventory , according to theabove principles, was adopted by the SCCNFP at the 4th Plenary meeting ( ) as aposition paper to be transmitted to Commission services and Amendments to the inventory (Section II)Technical discussions with EFFA representatives and JRC have been very fruitful towardsvery remarkable improvements in updating the fragrance inventory . After exchanging viewsand information, several comments and criticism on specific points of the list were discussedand satisfactorily resolved.

5 In particular, EFFA submitted a complete list of the ingredients ofbotanical origin, indicating the part(s) of the plant and the type of extractive(s) used for thesepurposes. These data have been incorporated in the present of the SCCNFPThe SCCNFP is of the opinion that this 1st Revision and Update of Section II of the Inventoryof ingredients employed in cosmetic products has usefully improved the inventory . Thisupdated Section II can to a greater extent fulfil the expectations of the consumer related totransparency and thus it is serving health main objective achieved has been the tabulation of the fragrance ingredients inalphabetical order by their more commonly known common names (when available),including also the restrictions or IFRA recommendations for safer use of each fragranceingredient (when pertinent).

6 Also, the revision in depth of the entries of all fragranceingredients of plant origin has been carried out by indicating the part of the plant used as wellas the type of extract obtained. Thus, nearly 310 entries were deleted, most of them beingincluded in the approximately 650 new entries of botanicals. The total number of entries isnearly 2750 increased by about 310. It is understood that the present 1st Updating of Section IIof the inventory is the best that could be achieved in the very limited time the inventory is an evolving document, the SCCNFP proposes the following provisions forthe next updating of Section II of the inventory :-Identification of a number of chemical materials of complex structure and chemicalname by more commonly known common or trivial names;-Addition or permanent deletion of entries of botanicals, that remained obscure at thepresent stage;-Addition of information about main constituents and commonly used names to thebotanical entries not including such information at present.

7 -Addition of information of tonnage yearly used for the most common fragranceingredients;-Adaptation of the chemical names of chemical substances included in Section II to thechemical names included in the respective CAS registry numbers;4-Improvement of the information given for botanical entries, considering in particular the following aspects: Volatile and fixed oils Species vs Variety of subspecies Problems detected on CAS numbers and EINECS/ELINCS numbers Clarification of questions regarding the availability of fragrance ingredientsobtained from different parts of the same plant in some cases List of synonyms Checking of warnings, restrictions or banning of some entries with a cleartoxicological concern-Clarification of some problems related to entries with peculiar names and/or unknownnature, such as Thaumatins (proteins), Stearoptenes, Octyl acetate monomethyl acetatederivative, Hydroformylation products, Pyroligneous acids reaction products withethyl alcohol distillates, I.

8 Introduction to the 1st Update of Section II of the InventoryAnnex II:1st Update of Section II of the inventory of ingredients employed in cosmeticproducts (perfume and aromatic raw materials)The Annexes are part of the IINTRODUCTION TO THE SECTION II OF THE 1st Update OF THE INVENTORY6 SECTION IIPERFUME AND AROMATIC MATERIALS1- PreambleThis list is representative for the basic materials used in perfumes and aromatic constitutes the updated inventory of fragrance materials, originally compiled on the basis ofinformation provided by EFFA (European Flavour and Fragrance Association) and publishedin the OJ No L 132, , p. 526 (Commission Decision 96/335/EC of 8 May 1996establishing an inventory and a common nomenclature of ingredients employed in cosmeticproducts).

9 This first Update of Section II of the inventory of Cosmetic ingredients has been prepared bythe SCCNFP in accordance with the provisions posed by Directive 93/35/EEC concerning therole of the inventory as a tool of transparency and, in particular, in order to enable theCommission to assess all issues relating to the use of cosmetics . The said Directive specifiesthat the inventory is compiled by the Commission on the basis of data provided by theindustry (Art. 5a (1)), and that the inventory must be periodically updated (Art. 5a (3)).According to the Annex of the Commission Decision 96/335/EEC, the first publication of theInventory was the best that could be achieved in the very short time limits imposed by theDirective 93/35/EEC.

10 Under these conditions Section II consisted of a list of ingredientsdefined by their chemical names, EINECS numbers and CAS registry numbers fulfillingrequirements of transparency as imposed by the original listing does not permit the ready identification of fragrance ingredients by theircommonly known trivial names predominating in scientific literature and textbooks. This firstupdate answers this problem by tabulating fragrance ingredients alphabetically by theircommonly known names if this first Update , the number of entries was increased by about 310, and their total numberis about of information included2-1 Common nameThis refers to common nomenclature of materials, which are readily recognized by experts inthe field, formulators and safety In general, the nomenclature conventions of Section I of the inventory have been alsoapplied in this 1st Update of Section II.