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Update of the Inventory of Ingredients Employed in Cosmetic Products

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Update of the Inventory of Ingredients Employed in Cosmetic Products SCCNFP/0389/00 Final THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS OPINION CONCERNING ST THE 1 UPDATE OF THE INVENTORY OF INGREDIENTS EMPLOYED IN COSMETIC PRODUCTS SECTION II: PERFUME AND AROMATIC RAW MATERIALS Adopted by the SCCNFP during the plenary session of 24 October 2000 1 1- Preamble Article 5a of the Cosmetics Directive 76/768/EEC stipulates that “the Commission shall compile an inventory of ingredients employed in cosmetic products …shall publish the inventory and shall update it periodically”. Accordingly Commission Decision 96/335/EEC of 8 May 1996 established the inventory and a common nomenclature of ingredients employed in cosmetic products. Furthermore the Cosmetics Directive specifies in the same Article 5a that the inventory is compiled “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 the current inventory. The task of the SCCNFP was elucidated by a mandate issued by the responsible service of the European Commission (SCCNFP/1891/98) which indicates that the SCCNFP shall act as a resource of scientific expertise to the European Commission, in terms of advising on the: 1. Medical and professional expectations and requirements of the Inventory. 2. Scientific accuracy and validity of proposed entries. 3. Outstanding needs of the existing text/proposed improvements in subsequent updates. In order to fulfil its work, scientifically based, the SCCNFP met experts from European Industry and worked in collaboration with the JRC (Joint Research Centre) of the Commission. The SCCNFP wishes to acknowledge in particular the co-operation of EFFA (European Flavour and Fragrance Association) and its scientific experts in establishing the 1st Update of Section II of the Inventory. The present document includes the opinion of the SCCNFP on the 1st Update of the Inventory of Ingredients employed in cosmetic products (Section II) and, in Annex, the Introduction to the Update and the Update of the Inventory (Section II) as adopted by the SCCNFP. 2- Position paper on Section II of the Inventory The Commission Decision 96/335/EC establishing the Inventory specified that “fragrance ingredients 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 labels using the words “perfume” or “flavour” (Article 6 (1) (g) of the Cosmetics Directive)”. Hence Section 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 Numbers. Since 1996, the members of the SCC/SCCNFP constantly expressed the opinion that the published form of the fragrance inventory was inadequate to serve its role posed by the 6th Amendment to the Cosmetics Directive because the numerical order makes scrutiny of the listing extremely difficult. It had been suggested that the listing should be changed to an alphabetical order, and that when a substance has an INCI name or is more commonly known by 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. It had also been suggested that other additional information should be included, such as main 2 constituents of ingredients of natural (plant or animal) origin, as well as information on the main fragrance ingredients by tonnage used. The document SCCNFP/0022/98 revising the Section II of the Inventory, according to the above principles, was adopted by the SCCNFP at the 4th Plenary meeting (23.11.1998) as a position paper to be transmitted to Commission services and EFFA. 3- Further Amendments to the Inventory (Section II) Technical discussions with EFFA representatives and JRC have been very fruitful towards very remarkable improvements in updating the fragrance inventory. After exchanging views and information, several comments and criticism on specific points of the list were discussed and satisfactorily resolved. In particular, EFFA submitted a complete list of the ingredients of botanical origin, indicating the part(s) of the plant and the type of extractive(s) used for these purposes. These data have been incorporated in the present update. 4- Opinion of the SCCNFP The SCCNFP is of the opinion that this 1st Revision and Update of Section II of the Inventory of ingredients employed in cosmetic products has usefully improved the Inventory. This updated Section II can to a greater extent fulfil the expectations of the consumer related to transparency and thus it is serving health protection. The main objective achieved has been the tabulation of the fragrance ingredients in alphabetical order by their more commonly known “common names” (when available), including also the restrictions or IFRA recommendations for safer use of each fragrance ingredient (when pertinent). Also, the revision in depth of the entries of all fragrance ingredients of plant origin has been carried out by indicating the part of the plant used as well as the type of extract obtained. Thus, nearly 310 entries were deleted, most of them being included in the approximately 650 new entries of botanicals. The total number of entries is nearly 2750 increased by about 310. It is understood that the present 1st Updating of Section II of the Inventory is the best that could be achieved in the very limited time available. As the Inventory is an evolving document, the SCCNFP proposes the following provisions for the next updating of Section II of the Inventory: - Identification of a number of chemical materials of complex structure and chemical name by more commonly known “common” or “trivial” names; - Addition or permanent deletion of entries of botanicals, that remained obscure at the present stage; - Addition of information about main constituents and commonly used names to the botanical entries not including such information at present; - Addition of information of tonnage yearly used for the most common fragrance ingredients; - Adaptation of the chemical names of chemical substances included in Section II to the chemical names included in the respective CAS registry numbers; 3 - 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 ingredients obtained from different parts of the same plant in some cases • List of synonyms • Checking of warnings, restrictions or banning of some entries with a clear toxicological concern - Clarification of some problems related to entries with peculiar names and/or unknown nature, such as Thaumatins (proteins), Stearoptenes, Octyl acetate monomethyl acetate derivative, Hydroformylation products, Pyroligneous acids’ reaction products with ethyl alcohol distillates, etc. Annex I: Introduction to the 1st Update of Section II of the Inventory Annex II: 1st Update of Section II of the Inventory of ingredients employed in cosmetic products (perfume and aromatic raw materials) The Annexes are part of the opinion. 4 ANNEX I INTRODUCTION TO THE SECTION II OF THE 1st UPDATE OF THE INVENTORY 5 SECTION II PERFUME AND AROMATIC MATERIALS 1- Preamble This list is representative for the basic materials used in perfumes and aromatic composition. It constitutes the updated inventory of fragrance materials, originally compiled on the basis of information provided by EFFA (European Flavour and Fragrance Association) and published in the OJ No L 132, 1.6.1996, p. 526 (Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products). This first update of Section II of the Inventory of Cosmetic Ingredients has been prepared by the SCCNFP in accordance with the provisions posed by Directive 93/35/EEC concerning the role of the Inventory “as a tool of transparency and, in particular, in order to enable the Commission to assess all issues relating to the use of cosmetics”. The said Directive specifies that the Inventory is compiled by the Commission on the basis of data provided by the industry (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 the Inventory was “the best that could be achieved in the very short time limits imposed by the Directive 93/35/EEC”. Under these conditions Section II consisted of a list of ingredients defined by their chemical names, EINECS numbers and CAS registry numbers fulfilling requirements of transparency as imposed by the Directive. The original listing does not permit the ready identification of fragrance ingredients by their commonly known trivial names predominating in scientific literature and textbooks. This first update answers this problem by tabulating fragrance ingredients alphabetically by their commonly known names if available. In this first update, the number of entries was increased by about 310, and their total number is about 2750. 2- Fields of information included 2-1 Common name This refers to common nomenclature of materials, which are readily recognized by experts in the field, formulators and safety assessors. - In general, the nomenclature conventions of Section I of the Inventory have been also applied in this 1st Update of Section II. Materials common in both sections of the Inventory keep their INCI name as common name in Section II, with only a few unavoidable exceptions, e.g. the name Damascone in Section I corresponds to cis-α-Damascone, which in Section II was named cis-Rose Ketone-1, because in Section II there are 4 Damascone isomers plus another 5 closely related materials, all of which are known as Rose Ketones. Such differences are identified in the List of Synonyms at the end of this section.
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